What's new outside the literature — FDA approvals, clearances, recalls, shortages, trials, Medicare coverage, guidance, and preprints. Updated daily.
The regulatory wire: FDA and global approvals, clearances, recalls, shortages, coverage, guidance, and trials — each a ranked daily briefing. Open any item on its source.
Bottom line. Critical shortages of atropine sulfate injection (discontinued), methotrexate sodium injection, and ropivacaine hydrochloride injection demand immediate formulary alternatives planning. A Health Canada recall of PMS-Fampridine for foreign material contamination and two carvedilol recalls for out-of-specification impurities require urgent dispensing review.
Medicare local coverage A57079:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L34218:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L34338:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L34056:
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Medicare local coverage L34082:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L34394:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52527:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A56799:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A56802:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52507:
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Medicare local coverage A57305:
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Medicare local coverage A56808:
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Medicare local coverage L36658:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L34541:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L38662:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L34032:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A56459:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L33947:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A55315:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A56451:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L38506:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A57884:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52837:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A56852:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Results posted 2026-10-08. Condition: Pancreatic Adenocarcinoma, Metastatic. A phase IIb, open-label, randomized study of Nab-Paclitaxel and Gemcitabine and plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer. Sponsor: Theriva Biologics SL. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Duchenne Muscular Dystrophy. The objective of this study is to assess the safety and tolerability of 10, 10, 20 milligrams per kilogram (mg/kg) ataluren in participants with nmDBMD who had prior exposure to ataluren in a PTC sponsored clinical trial or treatment plan, and siblings of those participants (prov. Sponsor: PTC Therapeutics. Status: TERMINATED. Phas
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Dry Age-related Macular Degeneration. This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD. Alcon Research, LLC, acquired LumiThera in September 2025.. Sponsor: LumiThera, Inc.. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Pediatric Cancer, Nutrition Related Cancer, Nutrition Aspect of Cancer, Muscle Loss. Nearly 60% of pediatric patients diagnosed with cancer develop malnutrition caused by a combination of disease burden, side effects of chemotherapy, and the intensity of cancer treatment. These patients are known to have an increased risk of infection, treatment-related toxici
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Contrast Enhancement in Magnetic Resonance Imaging, Central Nervous System Pathology. Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Nutrition, Food Selection, Food Preferences, Dietary Habits. The goal of this study is to determine whether certain front-of-package food labeling systems improve the healthfulness of consumers' grocery selections. US adults who are their households' primary shoppers will complete a shopping task in a naturalistic online grocery store. The. Sponsor: Harvard Pi
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Influenza, SARS-CoV-2. The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.. Sponsor: ModernaTX, Inc.. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Type1diabetes. The 4T program encompasses: Teamwork, Targets, Technology, and Tight Range. These methods will help patients better manage their condition of Type 1 Diabetes with improved patient-reported outcomes.. Sponsor: Stanford University. Status: ACTIVE_NOT_RECRUITING. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Healthy. The study will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cog. Sponsor: University of Minnesota. Status: COMPLETED. Phase: Phase 4.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Low Level Laser Therapy, Healthy, Postoperative Pain Management, Wound Healing. This randomized controlled clinical trial aims to evaluate the biomodulatory effects of a 940-nm GaAlAs diode laser on postoperative pain control and wound healing at the palatal donor site following free gingival graft harvesting. Adult patients undergoing free gingival graft su.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Aging. This study will test the effects of a social media game on the physical activity of older adult women. The game will consist of playful weekly challenges that require sharing photographs on a private social media group and also wearing an activity monitor to track steps. Particip. Sponsor: The University of Texas Medical Branch, Galveston. Status: COMPL
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Night Vision Complaints, Decrease in Night Vision, Disturbance; Vision, Loss. The objectives of this study are: * To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity * To evaluate the ocular and systemic safety of phentolamine mesyla. Sp
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Alpha1-Antitrypsin Deficiency. The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitryp. Sponsor: Grifols Therapeutics LLC. Status: COMPLE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Alcohol. Decisions during drinking (D3) is randomized clinical feasibility trial assessing whether health-related materials created for young adults who want to have more positive experiences if they decide to drink alcohol are acceptable and usable. Enrolled participants will be randomiz. Sponsor: University of Washington. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Peripheral Arterial Disease. Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to. Sponsor: Micro Medical Solution, Inc.. Status: ACTI
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Peanut Allergy. This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 µg or a placebo for a period of 6 months, after which all subjects will be receiving the active treat. Sponsor: DBV Technologies. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Major Depressive Disorder, Healthy Controls. The study is investigating dysfunctions in neurocircuitry in regards to irritability with healthy controls (HC) and individuals with Major Depressive Disorder (MDD) by performing MRIs. The MDD group will also be randomized to receive ketamine or midazolam to investigate changes p. Sponsor: University of Texas Southw
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: Obesity, Lifestyle-related Condition, Macrosomia, Fetal. Studies evaluating lifestyle intervention in obese women during pregnancy have reported limited success in decreasing excessive gestational weight gain, and have failed to achieve the key outcome of breaking the obesity cycle and reducing neonatal adiposity or birth weight. Altho. Sponsor: Tufts Medical
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-08. Condition: HIV. The goal of this behavioral study is to improve psychological well-being and optimization of HIV prevention and care outcomes for Men who have sex with men (MSM) in South Africa.. Sponsor: Emory University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collecti
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
→ New FDA guidance — may shift practice or documentation expectations.
Roche has inked a drug discovery deal with Chinese biotech Defand Therapeutics, focused on molecular glue medicines.
All six Nobel awardees in physiology or medicine, physics, and chemistry this year were men. Women make up 4% of laureates since the award’s inception.
Smaller biotech firms are trying to figure out how to win exemptions from Trump's import taxes.
Power House health committees could get a lot of new members after the midterms.
“A small, well-intended discount for safety net hospitals became a large institutional subsidy with expensive unintended consequences,” writes an HHS leader.
Eliminating hepatitis C is achievable — if the U.S. seriously invests in it, experts write.
A startup didn't want to wait for doctors and insurers to get behind its breast-cancer risk prediction AI. So it's going directly to patients.
There’s increasing evidence that older women with breast cancer could benefit from more tailored treatments. STAT Wunderkind Neil Carleton is working to make that a reality.
“Don’t google,” the pediatric geneticist warned. It took me five years to disobey.
FDA Approval of Daraxonrasib Marks Turning Point in Pancreatic Cancer Care Bioengineer.org
Sonorous wins FDA IDE for pulsatile tinnitus stent pivotal trial initiation Medical Device Network
FDA medical device recall system undercounts AEs Medical Buyer
IQVIA Launches Life Science Models to Predict Clinical Trial Outcomes Voice of Healthcare
Notice. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 13, 2023 (88 FR 62799). The notice announced the determination that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The notice did not include the determination that the abbreviated new drug applicat
→ New FDA guidance — may shift practice or documentation expectations.
Item(s): leadership change, other event, exhibits
The Justice Department issued a new directive for combating fraud that noted the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry.
A new study found that visits by people born outside of the U.S. to three LA emergency rooms dropped precipitously after ICE raids increased last year.
Henri B. Kagan and Kenso Soai were awarded the 2026 Nobel Prize in chemistry on Wednesday for solving a mystery with research on "mirror image" molecules.
Caribou Biosciences is shutting down after failing to raise the money necessary to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma.
Exon-skipping drugs present a critical test for the FDA’s goal of encouraging treatments for rare disease.
Key Democrats are meeting with MAHA activists and rolling out food and environmental plans to entice them.
“I reject the idea that a man who keeps every prostate cancer surveillance appointment has ‘untreated cancer,’” writes Howard Wolinsky.
Cerevance plans to meet with the FDA to “determine next steps” for a new kind of medicine known as solengepras, now that it has Phase 3 data in hand.
The company has integrated artificial intelligence scribing and camera-based vitals monitoring into its virtual care platform for hospitals as it works to recover from significant financial setbacks.
New FDA-Approved Treatment Offers Another Option for Adults With Fibromyalgia NBC Palm Springs
HeartSciences gets FDA clearance for MyoVista wavECG Mugglehead Investment Magazine
CurveBeam AI (ASX:CVB) FDA Clearance Raises the Stakes for Its Imaging Expansion Kalkine
Digital Health Networks launches pharmacy council Home | Digital Health
FDA Advisory No.2026-1507 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “UNBRANDED ARM SLING https://www.fda.gov.ph/
FDA Advisory No.2026-1506 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “HUAKUN BV FILTER” https://www.fda.gov.ph/
Results posted 2026-10-07. Condition: Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma. A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1).. Sponsor: Pfizer.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Neoplasms, Carcinoma. The financial burden, or financial toxicity (FT), of cancer is a consequential and growing problem, particularly for rural patients. It is important to improve our understanding of how financial navigation (FN) can reduce the material, psychological, and behavioral burden of cost. Sponsor: UNC Lineberger Comprehensive Cancer Center. Statu
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Spine Surgery, Reversal of Neuromuscular Blockade, Urinary Retention Postoperative. This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory spine surgery.. Sponsor: University of Missouri-
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Chronic Lymphocytic Leukemia. The purpose of this study is to determine the efficacy of bendamustine and rituximab (BR) followed by venetoclax for 12 months. The total time on therapy is 15 months. Bendamustine and rituximab is a commonly used treatment for CLL. Venetoclax is an oral drug that blocks a protei. Sponsor: Nicole Lamanna. Status: COMPLETED. Phase:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Parkinson Disease. It is a phase II randomized, parallel, double-blind, placebo-controlled, multi-center clinical trial of the efficacy and safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in patients with Parkinson's disease. The objective of the study is to access the safety and effi. Sponsor: Shanghai WD Pharmaceutical Co., Ltd.. Status: COMPLE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Diffuse Large-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL), High-grade B-cell Lymphoma (HGBCL). The purpose of the study is to evaluate whether receiving the pneumococcal 13-valent conjugate vaccine (PCV13) before and after CD19-targeted CAR T cell therapy will optimize cellular and humoral immunity to
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Birth Outcomes, Safety, Adverse Event Following Immunization. This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart). All participants will receive an mRNA COVID-19 vaccine at Visit 1 . Sponsor: Duke Univ
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Pain, Acute Postoperative, Renal Stone. This is a randomized, triple-masked, placebo-controlled parallel-arm human subjects clinical trial investigating the addition of a continuous erector spinae plane nerve block to a single-injection erector spinae plane block to provide postoperative analgesia following percutaneou. Sponsor: University of California, San D
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Sleep Apnea, Insufficient Sleep Syndrome, Sleep, Hypertension. The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness. In this study, the inve. Sponsor: Wayne St
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Facial isSCC. Open label, dose escalation to evaluate safety.. Sponsor: Sirnaomics. Status: TERMINATED. Phase: Phase 1, Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Surgery, Edema. The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-u. Sponsor: Firstkind Ltd. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Heart Failure. Approximately 6.5 million people have heart failure (HF) in the United States, and 960,000 new cases are reported each year. HF is one of the most common hospital diagnosis among older adults. About 40% of patients are readmitted within 1-year following their first admission for . Sponsor: University of Illinois at Chicago. Status: COMPLETED. Ph
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Gastroparesis. This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or . Sponsor: Dr. Falk Pharma GmbH. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Meningococcal Immunisation, Healthy Volunteers. This study was conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study was designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion. Sponsor: Sanofi Pasteur, a Sanof
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Hyperoxaluria. This pilot study is proposing a novel approach to directly target intestinal oxalate absorption with the drug Tenapanor, which was recently FDA-approved for treating hyperphosphatemia in patients with chronic kidney disease. Tenapanor works by blocking paracellular phosphate abso. Sponsor: University of Texas Southwestern Medical Center. Status:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Post Traumatic Stress Disorder. The investigators have developed a mobile app called Resolving Psychological Stress (REPS) for people with posttraumatic stress disorder (PTSD). The app will administer threat-related attention bias modification to individuals who score high on a PTSD checklist. This study will b. Sponsor: University of California, San Francisco
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Bronchiectasis. ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study was to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or . Sponsor: Sanofi. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Cancer Prevention, Weight Loss, Smoldering Waldenstrom Macroglobulinemia(WM), MGUS. This is a 4-month randomized trial of a prolonged nightly fasting intervention (PROFAST) in 40 overweight and obese individuals with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and smoldering waldenstrom macroglobulinemia (SWM).
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Granuloma Annulare. The primary objective is to determine if JAK1 specific inhibition is effective in treating granuloma annulare (GA), a problematic inflammatory skin disease without an FDA approved treatment. The primary outcome will be the percentage change in the body surface area (BSA) involvem. Sponsor: William Damsky. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Mesenchymal Stromal Cells, Cornea, Corneal Defect, Corneal Epithelium Defect. This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicag. Sp
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Antithrombin III Deficiency. To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.. Sponsor: Instituto Grifols, S.A.. Status: TERMINATED. Phase: Phase 2, Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Overweight, Obesity. Adults attempting weight loss through lifestyle modification (LM) typically find maintenance of behavior change difficult. Outcomes might be improved if participants are provided with sustained sources of accountability and support and ongoing opportunities to reflect with others. Sponsor: Drexel University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Parkinson Disease. Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop fashion that does not respond to a patient's current st. Sponsor: Stanford University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Brain Neoplasms, Adult, Malignant. SRS dose escalation for brain metastases in radiation-naïve patients will establish true tolerable doses, which may exceed the current standard doses. This may lead to an improvement in local control, patient survival, and/or quality-of life.. Sponsor: University of Texas Southwestern Medical Center. Status: ACTIVE_NOT_RECRUI
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-07. Condition: Cmv Congenital, CMV Viremia. The objectives of the protocol are to determine if a structured cognitive-behavioral interventional counseling of pregnant women can limit acquisition of human cytomegalovirus (HCMV) during pregnancy that we believe, will in turn decrease the incidence of congenital HCMV infectio. Sponsor: University of Alabama at Birmingham. Statu
→ New trial — a pipeline signal, not practice-changing yet.
New. Category: Cardiovascular. Form: Tablet. Reason: .
→ Shortage — anticipate substitutions and conserve supply.
Item(s): material agreement
Item(s): leadership change
About half of the patients in a study regained photosensitivity in their vision, showing the promise of optogenetics.
The Trump administration has proposed a $70,000 fee for a popular work authorization program meant to give students professional experience
The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.
In a setback for Merck, a Dutch court ordered a halt to the manufacturing and marketing of a subcutaneous formulation of Keytruda in several European countries.
Forbion, a prominent European venture capital firm, said it has raised $2.6 billion, its largest fundraise to date and one of the largest in the region in recent years.
In this edition of STAT's AIP Prognosis: Unresolved regulatory questions around Utah's AI sandbox, and more health AI news.
The World Health Organization released its first guidelines addressing the sharp rise in obesity among children and adolescents
Despite having an allogeneic cell therapy prospect that’s ready for late-stage testing in lymphoma, Caribou couldn’t secure funding to support the effort and will now pursue “strategic alternatives” instead.
A Dutch court barred Merck from selling subcutaneous Keytruda in several European countries. Elsewhere, an Insmed executive ended a seven-year run and two startups secured venture cash.
Kurz’s appointment comes as Medtronic enjoys strong growth in electrophysiology therapies thanks to demand for its pulsed field ablation devices.
The Medicines and Healthcare Products Regulatory Agency adopted 44 recommendations, including a call for AI-enabled devices to be monitored throughout their working life.
Patients can view their pulmonary artery pressure readings on their phone with the CardioMEMS updates, giving them a more active role in their care.
A U.S. district court ruled that Apple owes prejudgment interest on the $634 million in damages it incurred for infringing Masimo’s pulse oximetry patent.
Ken Paxton is on the hunt for evidence that UnitedHealth is breaking the Deceptive Trade Practices Act and other Texas laws, citing “alarming reports” of denied care.
Hanlon, who has worked in a variety of leadership roles at Highmark during nearly three decades with the company, will be the organization’s first-ever woman CEO.
Trilliant Health’s report identifies six trends highlighting how misaligned incentives are contributing to rising costs, poor health outcomes, workforce shortages and other systemic problems in U.S. healthcare. The post Trilliant Health: Misaligned Incentives Are Undermining US Healthcare appeared first on MedCity News .
Teladoc Health announced Wednesday that it is launching two new AI-powered capabilities built into its Solo smart care platform for hospitals and health systems to be used during virtual visits. The post Teladoc Health Adds Contactless Vitals and Ambient AI Scribe to Virtual Visit Platform appeared first on MedCity News .
Caribou Biosciences is stopping work on its two remaining cancer cell therapies and exploring strategic alternatives for the business. The move follows the CRISPR biotech company’s failure to secure financing for its clinical trial plans. The post Caribou Bio’s Journey With Off-the-Shelf Cell Therapy Reaches the End of the Road appeared first on MedCity News .
[Sponsored] Sponsored by Cotiviti, a webinar addressing the challenges of AI implementation and governance offered insights based on findings from the Healthcare AI Readiness Index. The post Constant Vigilance is the Watchword for Healthcare AI Governance appeared first on MedCity News .
Employers are trying to comparison shop in a market where all the price tags are hidden. And most can’t simply switch PBMs to find better pricing for their members. The post PBM Transparency Is Still Too Opaque — How Can Employers Rein In Drug Costs? appeared first on MedCity News .
No longer satisfied with buying pharmacies and clinics, it seems intent on owning the healthcare journey, and perhaps redrawing pharma’s commercialization map. The post From Distributor to Disruptor: Amazon’s Healthcare Flex appeared first on MedCity News .
Stanford-developed therapy treats first patient after FDA approval Stanford Medicine
Cedarville Stories: From Class Project to FDA-Approved Medical Device Cedarville University
MRI2CT Receives FDA Clearance for AI-Powered Imaging Platform Imaging Technology News
Highlighting the FDA Approval of Maintenance Tucatinib-Based Therapy in Advanced HER2+ Breast Cancer OncLive
Pearl Diagnostics Announces Publication of Clinical Studies Supporting FDA Clearance of MycoMEIA Business Wire
FDA approves breakthrough drug to treat advanced pancreatic cancer ABC News - Breaking News, Latest News and Videos
Dignify Therapeutics Receives FDA Clearance to Begin Clinical Trial of DTI-117 citybiz
NexTel Medical Corp. Announces Next-Generation Wellness Product Line Incorporating FDA-Approved Pharmaceuticals TradingView
FDA Approves Fayuvi, First Gene Therapy for Sanfilippo Syndrome Type A Denkstrom
Novartis Wins FDA Approval for Rhapsido in Symptomatic Dermographism Securities.io
Astaka Launches Health Tech Brand After Property Business Disposal. Moomoo
Astaka Launches Health Tech Brand After Property Business Disposal. www.marketscreener.com
Cigna Healthcare Launches Health Sense to Personalize Benefits, Care & Clinical Support Digital Health News
Results posted 2026-10-06. Condition: Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8. This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the can
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Mental Health Issue, Teamwork. Child Advocacy Centers (CACs) are well-positioned to identify children at risk for mental health problems and to facilitate access to evidence-based treatments. Implementation of standardized mental health screening and referral protocols may improve recognition of mental health . Sponsor: University of Pittsburgh. Status: COMPLE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Jaw, Edentulous, Partially. The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.. Sponsor: Dentsply Sirona Implants and Consumables. Status: ACTIVE_NOT_RECRUITING. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: None Volunteer. This study aims to compare the effectiveness of the new educational activity/game (a novel, engaging digital-training plus interaction with virtual patients to practice skills) in meeting clinical learning objectives and outcomes compared to traditional didactic (powerpoint slide. Sponsor: Medical University of South Carolina. Status: COMPLETED
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD. The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access..
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Carcinoma of the Anal Canal. This research study is a Pilot Study. Pilot studies are conducted to see if it is practical to do this type of research ona larger scale in the future. The pilot part of the study is to assess the possibility of using pencil beam proton radiation to treat your type of cancer. Pro. Sponsor: Massachusetts General Hospital. Status: CO
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Depressive Disorder, Major. The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\]) in all participa. Sponsor: Janssen Research & Development, LLC. Status
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Stage IIB Non-Small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer. Building upon the clinical experience of the investigators with the magnetic resonance (MR)-guided radiation therapy system and applying principals of hypofractionation toward the current treatment paradigm
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. This phase II Pediatric MATCH treatment trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that ha
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Asthma. The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma. Sponsor: GlaxoSmithKline. Status: ACTIVE_NOT_RECRUITING. Phase: Phase 4.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Glioma. Background: Diffuse midline gliomas are the most aggressive brain tumors of childhood and young adults. Most people with these tumors survive less than 2 years. Researchers want to see if an anticancer drug (abemaciclib) can help. Objective: To see if researchers can measure h. Sponsor: National Cancer Institute (NCI). Status: ACTIVE_NOT_RECRUITING.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma. This phase II MATCH treatment trial identifiesay block the protein tyrosine kinase WEE1 the effects of AZD1775 in patients whose cancer has a genetic change called BRCA mutation. AZD1775 may block a protein called WEE1, which may be needed for g
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Fascioliasis. The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6 years of age).. Sponsor: Novartis Pharmaceuticals. Status: COMPLETED. Phase: Phase 4.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Spinal Deformity. A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated wi. Sponsor: AO Foundation, AO Spine. Status: COMPLETED. Phase: N/
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Atrial Fibrillation. This clinical trial is being done to determine if metformin, a drug which is normally used in diabetes, can reduce atrial fibrillation in patients who are having an ablation for atrial fibrillation (AF). Atrial fibrillation is an abnormal heart rhythm which research has shown is . Sponsor: University of Michigan. Status: COMPLETED. Phase:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Dementia, Alzheimer Disease. The eRADAR Brain Health Study is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual care.. Sponsor: University of California, San Francisco. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Asthma. The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged \>=18 years with asthma. Sponsor: GlaxoSmithKline. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Depression, Adolescent - Emotional Problem. The goal of this placebo lead-in clinical trial was to test bright light therapy (BLT) in adolescents with depression. The main question\[s\] it aimed to answer were: 1. characterize and define facilitators/barriers to treatment with BLT in adolescents); 2. evaluate the acceptab. Sponsor: Ann & Robert H Lurie Childr
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Celiac Disease. The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD). Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All parti. Sponsor: Takeda. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Myelofibrosis. The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.. Sponsor: Bristol-Myers Squibb. Status: COMPLETED. Phase: Phase 1, Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Severe Aplastic Anemia. Background: People with severe aplastic anemia (SAA) do not make enough red and white blood cells, and/or platelets. Their body's immune system stops the bone marrow from making these cells. Immunosuppression (IST) with anti-thymocyte globulin (ATG) and cyclosporine (CSA) leads . Sponsor: National Heart, Lung, and Blood Institute (NHLB
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Leukemia, Lymphoma, Myelodysplasia. This is a single-arm study evaluating allogeneic hematopoietic stem cell transplantation (HSCT) using mobilized peripheral blood stem cells from unrelated or partially matched related donors that are ex vivo depleted of α/β T cells and CD19+ B cells using the CliniMACS device. Th. Sponsor: Children's Hospital of Philadelphia
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Multiple System Atrophy (MSA). This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of ONO-2808 in patients with MSA. This is the first study of ONO-2808 in patients with MSA.. Sponsor: Ono Pharmaceutical Co., Ltd.. Status: ACTIVE_NOT_REC
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: MDR-TB, HIV. The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs. The patients need to take these drugs for up to two. Sponsor: Johns Hopkins University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Acute Myeloid Leukemia. This phase Ib/II trial studies the effects of ASTX727 (decitabine and cedazuridine) in combination with venetoclax in treating patients with higher-risk acute myeloid leukemia patients who do not have a change in the gene called fms-like tyrosine kinase 3 (FLT3). Decitabine is in. Sponsor: National Cancer Institute (NCI). Status: ACTIVE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Cancer. A research study on the diagnosis of spread of disease for children who have been diagnosed with solid tumors using a new whole body imaging technique and a new MR contrast agent (ferumoxytol). Standard tests that are used to determine the extent and possible spread of a child's . Sponsor: Stanford University. Status: COMPLETED. Phase: Phase 1, Phase 2
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Long COVID, Long Covid19, Long Covid-19. This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key . Sponsor: Duke University. Status: COMPL
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-06. Condition: Kidney Cancer, Renal Cell Carcinoma, Unresectable Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma. Researchers are doing this study to find out if the combination of the drugs axitinib and talazoparib is a safe and effective treatment for people with your previously treated advanced kidney cancer. Researchers will look for the highest dose of talazoparib
→ New trial — a pipeline signal, not practice-changing yet.
Notice. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 7, 2026. The document announced the withdrawal of approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 8, 2026. The document indicated that FDA was withdrawing approval of ANDA 210285 for dimethyl fumarate delayed-release capsule, 120
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regula
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is classifying the high throughput DNA sequencing for hereditary cancer predisposition assessment test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the high throughput DNA sequencing for hereditary cancer predisposi
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA, Agency, or we) has determined that PRALIDOXIME CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) solution, 600 milligrams (mg)/2 milliliters (mL) (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for pralidoxime chloride solution, 600 mg/
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hyperoxia monitoring device adjunct to pulse oximetry. We are taking this action because we have det
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is classifying the focused ultrasound system for non-thermal, mechanical tissue ablation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the focused ultrasound system for non-thermal, mechanical tissue ablation. We are taking
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, and the first federally supported trials are expected to study ibogaine
→ New FDA guidance — may shift practice or documentation expectations.
Item(s): material agreement, results, other event
Item(s): leadership change, Reg FD, exhibits
When’s the best time to be vaccinated? Here are some thoughts that may help you make your decision.
Researchers found pulse oximeters went from overestimating blood oxygen levels to underestimating them; inaccuracies were worse in patients of color.
“We can document honestly and still wind up inflating hospital bills,” writes a frustrated doctor.
“Telling more people they have cancer is not progress; progress is having fewer people die from cancer,” H. Gilbert Welch writes of Grail’s multicancer screening test.
Longevity clinics promise personalized health advice and cutting-edge tests. Now major hospitals are entering the business, at costs reaching $45,000 a year.
Medical meetings often feature important clinical trial results, making them barometers of biotech and pharma companies’ research progress. Here’s a list of conferences to watch for in 2027.
The purchase expands GE HealthCare’s radiopharmaceutical capabilities, helping manufacture and distribute time-sensitive drugs used in PET imaging.
[Sponsored] A new report from ProgenyHealth offers a window into how the business works with commercial and Medicaid plans to close gaps in maternity and NICU care management that traditional programs overlook. The post Hidden Risks and Costs of Maternal/Infant Health that Health Plans Miss appeared first on MedCity News .
Tempus AI Stock After FDA Clearance for AI Heart Valve Detection Simply Wall Street
TELA Bio receives FDA clearance for resorbable mesh device Investing.com
Koita Foundation, ICMR Partner on Digital Health AI Voice of Healthcare
PMS-Carvedilol. Product quality
→ Class II recall — verify affected lots; temporary or reversible risk.
Carvedilol . Product quality
→ Class II recall — verify affected lots; temporary or reversible risk.
Item(s): results
Item(s): leadership change
WALTHAM, Mass., October 5, 2026 – Nova Biomedical initiated a global Medical Device Correction on July 24, 2026, for the StatStrip® Glucose Hospital Meter System due to a software issue that may cause a glucose result to be associated with the wrong patient. When a patient ID barcode is scanned, pri
→ Recall issued — check whether you stock the affected product.
Chill out about reports about plague in Siberia, writes infectious disease doctor Krutika Kuppalli.
AstraZeneca opened a new R&D site in Kendall Square yesterday, celebrating a $1 billion investment in the unsettled center of U.S. biotechnology after a spate of Chinese dealmaking.
Stem cells might be the next peptides, and how Trump's $90 checks will play out after the election.
What can hospital longevity clinics can tell you about your health? STAT's Sarah Todd went to one to find out.
In this edition of STAT Health Tech: New AI guidances expected from the the FDA in 2027, Utah expanding its AI sandbox, and more.
The Trump administration is advancing the first government-funded clinical trials of the psychedelic drug ibogaine to treat opioid addiction and PTSD
The fundraise is the firm’s largest to date, providing a lift for a European biotech industry that’s fallen further behind its counterparts in the U.S. and China.
More than half of the company’s value was wiped out by findings that appear to erase a chance to battle Johnson & Johnson and others for market share.
The better-than-expected results could make Epkinly the new “undisputed” treatment standard in newly diagnosed DLBCL, according to one analyst.
Cook Medical has become Zenflow’s U.S. distributor in a urology device market targeted by Boston Scientific, Olympus and Teleflex.
Lobo will step down on Dec. 31 as CEO after more than 15 years at Stryker. Chief operating officer Spencer Stiles will lead the company.
BD plans to increase U.S. production of essential medical consumables in exchange for relief from future tariffs on its products.
From AdvaMed’s meeting in San Francisco to a robotics conference in Rome, next year’s calendar is already filled with medtech events to attend.
The state has expanded its controversial healthcare AI program with three new pilots that could ultimately see the technology provide care plans and medications without human review.
Regulators warned two dozen hospital systems that incomplete or misleading pricing disclosures could violate federal consumer protection laws.
These are the best industry events for digital health, provider and payer leaders to attend next year.
Cybersecurity leaders discussed how AI-driven cybersecurity attacks pose a new level of risk for hospitals and health systems at Rubrik’s Healthcare Summit last week. The post Cybersecurity Experts to Hospital Leaders: Think Beyond Traditional Disaster-Recovery Planning appeared first on MedCity News .
The FTC sent warning letters to 24 major healthcare organizations over concerns about inadequate price transparency. The post FTC Sends Warning Letters to 24 Healthcare Organizations Over Price Transparency appeared first on MedCity News .
Forbion’s new capital will support two funds that will invest in about 30 companies combined. The new funds for Netherlands-based Forbion come amid a decline in VC fundraising and investments in Europe, according to Pitchbook. The post Forbion Bucks VC Fundraising Trends, Reeling In €2.3B for Two New Funds appeared first on MedCity News .
Perimenopausal anxiety isn’t simply in our patients’ heads. It’s often the result of complex physiologic changes involving hormones, sleep, metabolism, and the nervous system. The post Perimenopause Anxiety: Sometimes It’s a Progesterone Deficiency appeared first on MedCity News .
I kept hearing “medtech VC is in decline,” so I decided to dig into the data myself. I expected shrinking investor interest, inflated valuations, and a weak exit environment. Instead, I found a more nuanced story. The post MedTech VC 2026: The Real Story vs. The Thesis appeared first on MedCity News .
FDA-cleared cardiothoracic imaging tools being added to popular AI platform Cardiovascular Business
A Light-Based Treatment Is Now FDA Approved for a Common Skin Cancer Cure Today
Happy Health’s ring secures FDA clearance for blood pressure measurement Medical Device Network
Saluda Medical Expands Access to First and Only FDA-Approved Closed-Loop Surgical Paddle Lead with Full US Commercial Release of CAP24™ | Newswise Newswise
Virility Medical Launches in2 Smart Wearable Device in the United States, Bringing New FDA-Cleared Healthcare Technology to US Consumers FinancialContent
2026 fda approved weight loss drug retatrutide approval status www.polskieradio.pl
Immunome stock advances clinical pipeline after FDA clearance AD HOC NEWS
HeartSciences receives FDA clearance for MyoVista wavECG device By Investing.com Investing.com Canada
HeartSciences gets FDA clearance for MyoVista wavECG device TipRanks
Oku Digital Health launches from Topcon to link eye care, primary care Ophthalmology Times
Oku Digital Health Launches Globally From Topcon Healthcare to Expand AI-Driven Oculomics VisionMonday.com
Topcon Healthcare Launches Oku Digital Health to Connect Ocular Data with Systemic Disease Insights Eyewire+
Oku Digital Health Launches From Topcon Healthcare to Accelerate Drug Development Using Ocular Data GlobeNewswire
Oku Digital Health Launches Connected Care Solution to Unite Primary Care, Optometry, and Ophthalmology GlobeNewswire
Oku Digital Health Launches From Topcon Healthcare to Transform Eye Care Into Whole-Body Health GlobeNewswire
Medline Bariatric Rollator. Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
Embletta MPR PG. Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
Cardinal Health General Procedure Tray. Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
Results posted 2026-10-05. Condition: Diabetes Mellitus, Type 2, Diabetes, Type2diabetes. The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control a. Sponsor: Beijing Supreme Lif
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Bacterial Vaginosis. This was a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed with bacterial vaginosis (BV) (Part B).. Sponsor: BioNTech SE. Status: COMPLETED. Phase: Phase 1.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Schizophrenia. This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).. Sponsor: Intra-Cellular Therapies, Inc.. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Irreversible Pulpitis, Apical Periodontitis, Pulpitis. Statement of problem: Although performing full pulpotomy in mature permanent molars with irreversible pulpitis showed success rates comparable to RCT, there is a growing need for further studies in order to determine the predictability of pulpotomy in teeth with apical periodonti. Sponsor: Misr Internation
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Cancer, Survivorship, Caregiver Burden, Psychological Distress. The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.. Sponsor: Massachusetts General Hospital
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Pain, Chronic. This study will investigate effects of a psychoeducation pain management skills intervention on adults with persistent pain by training a cohort of American Society for Pain Management Nursing (ASPMN) nurses to deliver and it \[Empowered Relief (ER)\], as a single-session video-c. Sponsor: Washington State University. Status: COMPLETED. Phase: N
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Kidney Stones, Nephrolithiasis. The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.. Sponsor: Vanderbilt University Medical Center. Status: COMPLETED. Phase: Phase 4.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases. The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis. The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until w
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders, Delusional Disorder. This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.. Sponsor: Columbia University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Parkinson Disease. The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.. Sponsor: Boston Scientific Corporation. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Developmental Language Disorder. This is a small-scale treatment study designed to determine which teaching methods result in the best learning. Treatment focuses on helping children with a developmental language disorder learn parts of grammar. Preschool children will receive assessments to determine whether th. Sponsor: University of Arizona. Status: COMPLET
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Chronic Graft-versus-host-disease. This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD).. Sponsor: Incyte Biosciences Japan GK. Status: ACTIVE_NOT_RECRUITING. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Minimal Flow Anesthesia, General Anaesthesia, Inhalation Anesthesia, Infection Risk. This study is being done to find out if the heat and moisture that build up during minimal flow anesthesia can lead to the growth of germs (microorganisms) inside the anesthesia equipment. Minimal flow anesthesia (using fresh gas flow of 0.5 liters per minute or less) is known
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Urgency Urinary Incontinence. Urge urinary incontinence (UUI) is a common problem in older people which vastly reduces quality of life, yet the cause and mechanism of disease are not well understood. This study will characterize brain control of the bladder in young and old continent individuals and age-match. Sponsor: University of Pittsburgh. Status: COMPLET
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Intensive Care, Oral Care, Intubated ICU Patients. There are several practical challenges in providing oral care to intubated patients. The presence of an endotracheal tube often makes it difficult to thoroughly evaluate the oral cavity, and there is a risk of tube displacement or removal during oral care. Additionally, the lack . Sponsor: Saglik Bilimleri Uni
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-05. Condition: Fatty Liver, Nutritional and Metabolic Disease. A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and gut microbiota composition in participants with NAFLD. Participants will be allocated randomly to a. Sponsor: University of Nottingha
→ New trial — a pipeline signal, not practice-changing yet.
Vaxcyte said its experimental pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up the biotech to compete with Pfizer and Merck.
What science says so far about which cancers can be beat by vaccines — and which will require more creative approaches.
Karl Deisseroth, Peter Hegemann, and Georg Nagel are the joint recipients of the 2026 Nobel Prize in Physiology or Medicine “for their discoveries concerning light-gated ion channels and optogenetics," the…
Peptides gained legitimacy at the FDA after being embraced by MAHA. Advocates hope stem cell treatments will follow the same path.
“Are we entering a world in which some (or all) Nobels will be awarded to Claude, ChatGPT, or their AI successors, rather than human scientists?” asks Jeffrey Flier.
A melanoma vaccine succeeded in a late-stage clinical trial. The question now is whether other cancer vaccines will work — and whether mRNA is up to the task.
Workers and employers are drowning in their health insurance premiums. The reason for that deluge: the health care industry’s high and inscrutable prices.
“In the absence of population-based evidence, the energy drink cabal is having an easy time of it,” writes Kent Sepkowitz.
Why diagnostic-driven therapies need a new commercialization model to reach more eligible patients.
As AI accelerates drug discovery, here are the ways pharmaceutical manufacturing facilities are adapting.
Thermo Fisher turned fragmented KOL data into real-time market demand. Read how.
Patient access problems often start with fragmented workflows, not staffing alone.
The health insurance industry does not simply need another point solution. It needs the connective tissue that allows existing investments to collaborate.
[Sponsored] Fraud, waste, and abuse (FWA) continue to challenge dental plans as overtreatment, miscoding and inappropriate billing practices drive unnecessary costs and weaken payment integrity. For dental payers, the stakes extend beyond financial losses: these issues can also expose members to unnecessary procedures and consume benefits that should be preserved for appropriate care. The post
Norgine Limited is recalling specific batches of product as a precautionary measure due to some units containing the incorrect amounts of active ingredients.
→ Recall issued — check whether you stock the affected product.
Surrozen secures FDA clearance for SZN-8141 clinical trial Clinical Trials Arena
HanchorBio Announces U.S. FDA Clearance of IND Application for HCB303, a Next-Generation Trispecific Immunotherapy Morningstar
Lilly Secures FDA Approval to Expand Jaypirca Indication Intellectia AI
Immunome stock gets FDA clearance for fifth clinical program AD HOC NEWS
Averly Health launches in UK to advance cardiometabolic care Medical Device Network
Elevate Holistics Launches Telehealth Platform for At-Home, Low-Dose Ketamine Care FinancialContent
Elevate Holistics Launches Telehealth Platform for At-Home, Low-Dose Ketamine Care manilatimes.net
Item(s): results, exhibits
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.
Black specks and particulate reported in drip chambers of certain ICU Medical IV tubing sets does not affect device safety, performance, or intended use.
→ Recall issued — check whether you stock the affected product.
BD Alaris Pump Infusion Sets are being removed and discontinued; Alaris Pump Module model 8100 has updated performance data
→ Recall issued — check whether you stock the affected product.
Federal judges pushed back against the government's arguments in a Medicare Advantage case.
Optogenetics is now the foundational way through which we are able to understand how the brain works
The Trump administration is continuing its effort to bring more transparency to the cost of health care.
Why is health insurance so expensive? Read the latest stort in STAT's "Out of Pocket, Out of Reach" series to find out.
Utah plans to allow an AI product to evaluate patients and write new drug prescriptions without prior human review.
Eli Lilly’s Jaypirca has won FDA approval for previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma.
Vaxcyte said its pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up a competition with Pfizer and Merck
The acquisition of Texas-based IntraBio adds to a growing rare disease business for Shionogi by handing the company a marketed treatment for two inherited conditions.
The Nobel laureates “laid the foundation” for a new field of brain research, the award committee wrote. Elsewhere, Roche and CSL cut licensing deals and the FDA endorsed broader use of a Lilly medicine.
The company’s next-generation shot surpassed Wall Street’s expectations by matching the effectiveness of vaccines from Pfizer and Merck on nearly all bacterial strains in the first of three Phase 3 trials.
Jonny Mason, who became CEO of the medtech firm a year ago following the death of Karim Bitar, said Convatec’s pace of launching new devices has accelerated for 2026 and 2027.
Four organizations will develop devices for tracking heart disease, inflammation and perimenopause.
On Monday, the HHS and Labor and Treasury Departments finalized a rule meant to strip out junk cluttering cost disclosures, among other reforms. Employers cheered the changes, which are a mixed bag for insurers.
About 20.8 million beneficiaries will receive a direct deposit or check this month, the latest in a growing list of cash payments promised by the White House in advance of the November midterm elections.
Launched last week, Facktor Ventures, an early-stage venture fund is taking a new approach to healthcare investing: they’re structured so that the organizations delivering care on the ground collectively become majority owners of the fund as limited partners. The post Investing in Community Health: A New Model for Safety-Net Healthcare Innovation appeared first on MedCity News .
Shionogi’s IntraBio acquisition brings Aqneursa, a drug approved for treating two rare neurological disorders and the potential to expand to additional indications, both rare and common. It’s Shionogi’s second big rare disease move this year, following the acquisition of global rights to an amyotrophic lateral sclerosis drug from Tanabe Pharma. The post Shionogi Adds to Its Rare Disease Strate
The Trump administration is issuing one-time $90 payments to more than 20 million Medicare beneficiaries to help cover Part B premiums, though the payments may do little to offset rising healthcare costs. The post Trump Administration Announces $90 Payments to Help Cover Medicare Part B Premiums appeared first on MedCity News .
Nobody has ever needed convincing on what to fix. What they’ve lacked is a way to act on it themselves, in something close to real time instead of on a vendor’s roadmap. The post The Biggest Healthcare Fix Might Not Come From a Vendor appeared first on MedCity News .
AIRS Medical secures FDA clearance for MRI software AuntMinnie
Tele-Vision: How Recent FDA and SEC Actions Forecast a Sharper Focus on Telehealth Prescribing Models ArentFox Schiff
PDP-DIPHENHYDRAMINE. Product quality
→ Class II recall — verify affected lots; temporary or reversible risk.
Lumify Ultrasound System. Performance
→ Class I recall — stop use, check your stock, switch to alternatives.
AML Drug Moves Into Clinical Trials Following FDA Clearance Technology Networks
Elevate Holistics Launches Telehealth Platform for At-Home, Low-Dose Ketamine Care The Manila Times
FDA application ANDA090363 approved. DESFLURANE DESFLURANE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA213796 approved. DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA213159 approved. CARBAMAZEPINE CARBAMAZEPINE, CARBAMAZEPINE CARBAMAZEPINE, CARBAMAZEPINE CARBAMAZEPINE
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA008372 approved. ACTHAR GEL CORTICOTROPIN, ACTHAR GEL (AUTOINJECTOR) CORTICOTROPIN, ACTHAR GEL (AUTOINJECTOR) CORTICOTROPIN. Class: Adrenocorticotropic Hormone [EPC]
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA009854 approved. CORTROPHIN-ZINC CORTICOTROPIN-ZINC HYDROXIDE
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA008975 approved. PURIFIED CORTROPHIN GEL CORTICOTROPIN, PURIFIED CORTROPHIN GEL CORTICOTROPIN
→ Newly FDA-approved — consider where it fits among current options.
MIT class project turns into an FDA-cleared treatment for tremors WebWire
President Trump is promising more payments to voters just ahead of the Nov. 3 midterm elections — this time for seniors' Medicare Part B premiums
While the immune reset field is mainly focused on depleting pathogenic B cells, ai3Bio is applying its novel approach to inflammatory T cells. The startup’s initial disease targets are autoimmune disorders of the liver that have few treatment options if any at all. The post Immunology Startup ai3Bio Aims to Redefine What It Means to Reset the Immune System appeared first on MedCity News .
The Trump administration’s ACA fraud crackdown will remove 760,000 people from Marketplace coverage, drawing criticism from healthcare experts and advocates. The post Trump’s ACA Fraud Crackdown: Experts Urge Going After Bad Actors, Not Patients appeared first on MedCity News .
Rural patients, Medicaid enrollees, and patients from underrepresented racial and ethnic groups are more likely to go undiagnosed, more likely to be misdiagnosed, and more likely to end up in an emergency department rather than an allergist’s office. The post Closing the Diagnostic Gap: Why Access to Allergy Care Isn’t Equal appeared first on MedCity News .
At a recent symposium on privacy, experts discussed how AI supports a faster and oftentimes more insightful approach to data security, while identifying which privacy risks healthcare organizations must monitor. The post Healthcare Privacy Leaders Look to AI to Improve Monitoring and Data Breach Investigations appeared first on MedCity News .
DeepHealth Gains FDA Clearance for Chest XRay CADe Solution Applied Radiology
APLMS and VSee to Build Asia-Pacific Digital Health Infrastructure for Healthy Longevity and Active Aging Cincinnati Enquirer
Most red light therapy devices aren't FDA-cleared. These are. Yahoo
fda approved glp-1 drugs for weight loss 2026 www2.polskieradio.pl
FDA Approves First Growth-Adjustable Heart Valve for Children with Congenital Heart Defects Voice of Healthcare
News of a fifth measles death in Pennsylvania underscores a longstanding issue about the disease. The full scope of the outbreak — in the state and in the country —…
The NIH continued reducing grants involving health disparities, race, and ethnicity but made little progress toward other administration priorities in the 2026 fiscal year.
The law has to catch up on the 340B drug discount program, writes a pharmacist.
A doctor’s request to marathons: Let’s make evidence-based medical plans — especially for extreme heat.
[Sponsored] In this webinar pharmacy leaders share how hospitals are using stewardship as a sustainability strategy to control costs and ease the load on pharmacists. The post Hospitals’ Cost Containment Conundrum appeared first on MedCity News .
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety…, Agenda Agenda of the PRAC meeting 28 September - 1 October 2026Draft Reference Number: EMA/PRAC/204838/2026…, PRAC statistics: October 2026 Monthly figures for PRAC outcomes b
MIT class project turns into an FDA-cleared treatment for tremors MIT News
SciPinion Launches AI Tool to Benchmark New Ingredients Against FDA-Cleared GRAS Precedents vegconomist.com
Edwards Lifesciences wins FDA approval for AUTUS Mugglehead Investment Magazine
MIT Class Project Becomes FDA-Cleared Tremor Treatment After Nine-Year Journey news.lavx.hu
FDA greenlights Edwards’ expandable pulmonary valve for paediatric patients Medical Device Network
Results posted 2026-10-02. Condition: Burnout, Compassion Satisfaction, Secondary Trauma. The investigators propose to develop and test the effectiveness of PATH (Peer Advanced Training for total Health) as an educational workforce intervention for improving peer recovery support specialists' (PRSS) overdose prevention (OP) service delivery ability and quality and as . Sponsor: Chestnut Health Sys
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Alcohol Drinking. This study seeks to better understand mechanisms of behavior change for heavy drinkers who are interested in changing their drinking. The study will examine the effects of CBM as an adjunctive treatment on neurocognitive processes related to alcohol use in a sample of heavy/at-ri. Sponsor: Boston University Charles River Campus. Status: TERMI
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Obstructive Sleep Apnea. The objective of this protocol is to conduct a focus group to identify OSA beliefs, attitudes, and knowledge among employees in the transportation industry on shift schedules.. Sponsor: Brigham and Women's Hospital. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Colorectal Carcinoma. This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in their liver.. Sponsor: Jennerex Biotherapeutics. Status: TERMINATED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Healthy Adult Subjects. To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.. Sponsor: Eli Lilly and Company. Status: COMPLETED. Phase: Phase 1.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Nicotine Addiction, E-Cig Use, Cigarette Smoking, Sex Differences. The primary objective is to examine the influence of sex on sensory effects, appeal, and reinforcing value of nicotine containing e-cigs in popular flavor components; sweet and cooling.. Sponsor: Yale University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm. This clinical trial examines a web-based tool, in partnership with Peacefully, Inc, designed to improve end-of-life planning among patients with advanced cancers. This program helps users prepare comprehensively for end-of-life (e.g., med
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases. This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII with HiFocus electrode).. Sponsor: Advanced Bionics. Status: C
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Aging, Depression, Cognitive Symptom. This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime episodes; either current or within past 3 years).. Sponsor: Vanderbilt University Medical Center. Status: COMPLETED. Phase:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Ovarian Cancer, Fallopian Tubes Cancer, Peritoneal Cancer. The purpose of this study is to see if the investigators can improve the treatment of this type of cancer. They want to find out what effects, good and/or bad, giving heated chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has on the patien. Sponsor: Memorial Slo
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Healthy. To investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects. Sponsor: Boehringer Ingelheim. Status: COMPLETED. Phase: Phase 1.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Breast Cancer. The goal of this study is to increase MRI utilization among women with extremely dense breasts. The main question it seeks to answer is whether nudging of the provider, patient, or both increases the uptake of MRI among this group, and whether this effect differs between Black an. Sponsor: Abramson Cancer Center at Penn Medicine. Status: COMPLET
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Non-Small Cell Lung Carcinoma. The Drugs Controller General of India (DCGI) granted approval for Rahika® (capmatinib) film-coated tablets (150 mg and 200 mg) for the treatment of adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbored a mutation leading to mesenchyma. Sponsor: Novartis Pharmaceuticals. Status: COMPLE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-02. Condition: Autism Spectrum Disorder. The goal of this clinical trial is to learn about occupational therapy integrating horses for autistic youth. The main questions it aims to answer are: * Does occupational therapy integrating horses improve self-regulation in autistic youth * Does occupational therapy integratin. Sponsor: Colorado State University. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy.
→ Recall issued — check whether you stock the affected product.
The redesign is intended to streamline what was a sprawling and fractured information ecosystem, requiring users to understand NIH's organizational structure
Ahead of this year's Nobel Prize announcements, STAT chatted with Mary-Claire King, who discovered the BRCA cancer mutations and is frequently mentioned in prize predictions.
Only a small fraction of young people with opioid use disorder receive addiction medications, and few stay on them for long, a study finds.
Congo's Ebola outbreak has killed more than 4,000 people, authorities said, as they struggle to contain what has become the fastest-growing Ebola outbreak in history.
Eli Lilly is launching LillyDirect to deliver Mounjaro straight to Australian patients’ doors — and local doctors and pharmacists aren’t thrilled.
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
The U.S. approved 10 drugmakers to participate in a 340B pilot program that will allow them to offer rebates, instead of upfront discounts, to certain providers
The latest installment in BioPharma Dive’s data visualization series features a closer look at Kodiak’s stock performance and Hengrui's ties with U.S. and European drugmakers.
The device could help young patients avoid multiple open-heart surgeries as they grow, FDA officials said.
The FDA outlined its A-list and B-list guidance priorities for the 2027 fiscal year.
Independence Blue Cross will pay to settle allegations it defrauded Medicare by inflating diagnosis codes for MA beneficiaries. The payer cited “industry-wide challenges” in applying MA risk adjustment standards.
Debunked Podcast co-hosts Arundhati Parmar and Samir Batra discussed the merits of the CMS ACCESS Model (Advancing Chronic Care with Effective, Scalable Solutions) and how it can offer a path to advance value-based care goals. The post Debunked Episode 30: ACCESS Tries to Succeed Where VBC Fails, AI, and UnitedHealth Gets the Last Week Tonight Treatment appeared first on MedCity News .
The Series A round was led by Canvas Ventures, with participation from Blank Space Ventures, StoryHouse Ventures and HMC INQ. The post Parakeet Health Secures $10M for Conversational Agentic Platform appeared first on MedCity News .
Pfizer’s Litfulo significantly improved skin pigment measures in two pivotal studies in vitiligo, results that were presented during the European Academy of Dermatology and Venereology annual meeting. If Pfizer’s daily pill is approved, it would compete against an Incyte topical cream that is currently the only FDA-approved therapy for this autoimmune skin disorder. The post Pfizer Pill’s Phase
Data, behavioral insights, and experimentation can be used to understand how stress, motivation, and trust shape company culture. Positively changing company culture leads to direct improvements in patient health outcomes, clinician wellbeing, and company performance. The post It’s Time We Reframe Healthcare Organizational Culture Using Behavioral Science appeared first on MedCity News .
This report describes 48 confirmed cases and one probable case of C. bantiana in clinical samples from 2009-2026.
→ New FDA guidance — may shift practice or documentation expectations.
Edwards’ adjustable heart valve for children lands FDA approval MedTech Dive
Visiana gets FDA clearance for BoneXpert bone age software AuntMinnie
Sanfilippo Syndrome Gene Therapy FDA Approved for Childhood Dementia European Medical Journal
AUTUS Valve Wins FDA Approval for Children Tech My Money
Surrozen to Advance Potential Eye Drug into Clinical Development Following FDA Clearance marketscreener.com
mounjaro fda approved for weight loss www.polskieradio.pl
UKRI launches £80m ‘Dementia Challenge’ programme Medical Device Network
Digital COPD programme launches across North West London Home | Digital Health
Carevo Shower Trolley. Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
Precision Pointer Electromagnetic (EM). Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
Automated Impella® Controllers (AIC). Performance
→ Class I recall — stop use, check your stock, switch to alternatives.
In exchange for a $575 million payment up front, Abogen Biosciences will furnish Novartis with access to its RNA technology, including an option to license its lead program ABO-2203.
The governors of Oregon, California, Maine, New York and Virginia don’t think it’s possible for states to meet the Jan. 1 deadline to stand up work requirements while protecting beneficiaries.
With FDA approval, Lilly’s BTK drug Jaypirca enters first-line CLL Fierce Pharma
FDA application ANDA212491 approved. CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE, CYPROLARA CYPROHEPTADINE HYDROCHLORIDE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA211860 approved. FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA020802 approved. EXCEDRIN (MIGRAINE RELIEF) ACETAMINOPHEN. Class: Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Central Nervous System Stimulant [EPC], Cyclooxygenase Inhibitors [MoA]
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA091433 approved. DOXERCALCIFEROL DOXERCALCIFEROL, DOXERCALCIFEROL DOXERCALCIFEROL, DOXERCALCIFEROL DOXERCALCIFEROL
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA216059 approved. JAYPIRCA PIRTOBRUTINIB, JAYPIRCA PIRTOBRUTINIB. Class: Kinase Inhibitor [EPC], Bruton's Tyrosine Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA206840 approved. METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA220492 approved. PERAMPANEL PERAMPANEL, PERAMPANEL PERAMPANEL, PERAMPANEL PERAMPANEL
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA213301 approved. CELECOXIB CELECOXIB, CELECOXIB CELECOXIB, CELECOXIB CELECOXIB. Class: Nonsteroidal Anti-inflammatory Drug [EPC], Cyclooxygenase Inhibitors [MoA]
→ Newly FDA-approved — consider where it fits among current options.
fda-approved weight loss drugs telehealth new jersey 2025 BusinessWorld Online
Medicare local coverage DL40462:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage DL40454:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A56743:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage DL40456:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage DL40458:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage DL40441:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52479:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52480:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L33317:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L33824:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52458:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L33686:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L33788:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L33791:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52457:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52497:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A52503:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage DL40439:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L36402:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage L33417:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A57473:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare local coverage A56559:
→ Coverage decision — check reimbursement / formulary impact for your patients.
Results posted 2026-10-01. Condition: Dry Age-related Macular Degeneration. This is a phase 2, double-masked, randomized, placebo-controlled, dose-response study. The primary objective of the study is to evaluate the efficacy of QA102 oral capsules on the development of soft drusen, visual acuity (VA), and geographic atrophy (GA) or choroidal neovascular. Sponsor: Smilebiotek Zhuhai Limited. Statu
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Mesothelioma, Pleural Mesothelioma, Malignant Pleural Mesothelioma. Patients with pleural mesothelioma (PM) that cannot be surgically removed will receive standard chemotherapy (cisplatin or carboplatin and pemetrexed) given with durvalumab, a type of immunotherapy, or a treatment chosen by the study doctor, which is either standard chemotherapy . Sponsor: PrE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Pediatric Obesity, Nutrition Disorders, Binge Eating, Body Weight. This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral a. Sponsor: Stat
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Acne Vulgaris. The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) for the medication Ameluz® performed with the PDT-lamp BF-RhodoLED® in comparison to the respective placebo treatment for moderate to severe Acne vulgaris.. Sponsor: Biofrontera Inc.. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: HIV Infections. The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementati. Sponsor: ViiV Healthcare. Status: COMPLETED. Phase: Phase 4.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Heart Failure. The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA. Sponsor: CVRx, Inc.. Status: TERMINATED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Androgenetic Alopecia. The purpose of this study is to characterize the safety, tolerability, and efficacy of topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with Androgenetic Alopecia (AGA).. Sponsor: Biosplice Therapeutics, Inc.. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Hepatocellular Carcinoma. This was a Phase 2 trial composed of an open label Lead-In followed by a planned Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo (inactive substance) in combination with atezolizumab plu. Sponsor: Coherus Oncology, Inc.. Status: TERMINATED. P
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Type 2 Diabetes. The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The . Sponsor: Eli Lilly and Company. Status: COMPLETED. Phase: Phase
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Diabetes Mellitus, Type 2, Hypertension. The purpose of this study is to investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support.. Sponsor: Duke University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: HNSCC, Lip SCC, Oral Cavity Cancer, Oropharynx Cancer. This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1 inhi. Sponsor: University of Ca
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: IgA Nephropathy, Berger Disease. A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3). Sponsor: Vera Therapeutics, Inc.. Status: ACTIVE_NOT_RECRUITING. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Colon Cancer, Colon Polyp, Diverticular Diseases, Inflammatory Bowel Diseases. For patients with colon polyps (clumps of cells in the lining of the colon) treatment often requires removal of the affected portion of the colon. Both conventional laparoscopic and robotically assisted minimally invasive surgery have been shown to have reduced complication rates. S
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Androgenetic Alopecia. This study will assess the safety, tolerability, and efficacy of SM04554 at concentrations of 0.15% and 0.25%. Improved knowledge of the changes in hair counts and immunohistochemical analysis associated with androgenetic alopecia (AGA) before and after treatment with SM04554 and. Sponsor: Biosplice Therapeutics, Inc.. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Stone, Kidney, Ultrasound Therapy; Complications. The purpose of this study is to assess the accuracy of ultrasound and traditional fluoroscopy to find the residual fragments before retrograde intrarenal surgery is complete. This would ultimately limit the need for radiation exposure and improve the quality of clinical care give. Sponsor: University of Califor
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Androgenetic Alopecia. This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects.. Sponsor: Biosplice Therapeutics, Inc.. Status: COMPLETED. Phase: Phase 2, Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Depression. The investigators will administer theta burst stimulation (TBS) in efforts to observe a decrease in severity of reported depression symptoms. A subset of participants will receive positive affect training during this intervention.. Sponsor: Erika Forbes. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Agitation, Dementia. A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed \[PRN\]), for a maximum of 168 doses within a 12-week treatment period.. Sponsor: BioXcel Therapeutics Inc. Status: TERMINATED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Inclusion Body Myositis. A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis. Sponsor: Abcuro, Inc.. Status: COMPLETED. Phase: Phase 2, Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Child, Intensive Care Unit Acquired Weakness, Critical Illness, Hospital Acquired Pressure Ulcer. While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Traumatic Brain Injury. The most persistent and disabling postconcussive symptoms following mild traumatic brain injury (mTBI) are sleep disturbances and cognitive dysfunction, with few tractable interventions currently available. Here, a novel therapy will be tested consisting of dietary supplementatio. Sponsor: VA Office of Research and Development. Status:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Infection, Sepsis, Obesity. Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vanco. Sponsor: CAMC Health System. Status: COMPLETED. Phas
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Gastrointestinal Cancers, Cholangiocarcinoma, Gastric Cancer, Colorectal Cancer. Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of \[18F\]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-10-01. Condition: Overweight and Obesity. This study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic risk factors.. Sponsor: University of Utah. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Notice. The Food and Drug Administration (FDA) is announcing the renewal of the Antimicrobial Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Antimicrobial Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA) is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or pane
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA or Agency) is requesting nominations for qualified individuals to serve as voting members of FDA's standing public advisory committees and panels (collectively, advisory committees). This notice covers scientific, technical, professional, and other voting-member positions in which appointees serve as individuals rather than as designated representative
→ New FDA guidance — may shift practice or documentation expectations.
DHS has appealed a court ruling blocking it from restricting how long international students and postdoctoral researchers can remain in the U.S.
The small biotech company Invivyd is developing an injectable, low-dose monoclonal antibody to protect against Covid.
Questions about the durability of an experimental Huntington's disease therapy matter to Wall Street. They matter less to those directly affected by the disease.
A small conference with big ambitions mirrors the rapid growth of Chinese biotech, invites comparisons to U.S. biotech gathering also known for deal-making.
In Washington, Eric Cantor will confront bipartisan backlash over rising health care costs.
Senate committees that handle important health care matters are about to see major GOP turnover. Here's what that means.
“Intervening in childhood could save children from decades of irreversible damage,” a transplant surgeon writes of GLP-1 weight loss drugs.
In 2009, analyzing Euan Ashley’s whole genome took 30 people and almost a year. In 2026, he writes, Claude did it in 30 minutes for about $5.
Sanofi and Regeneron have re-upped their collaboration pact, aiming to build on the blockbuster success of the drug Dupixent.
Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information and the corresponding refe…
→ Recall issued — check whether you stock the affected product.
EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and…
Amsterdam, 28 September 2026Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)Good morning,…
Everlywell Brings Clairity’s FDA-Authorized AI Breast Cancer Risk Assessment to Women Nationwide Business Wire
Get 15% off Hushd Avera, an FDA-cleared anti-snoring solution USA TODAY 10BEST
Capricor's Deramiocel FDA Approval Decision Approaches Intellectia AI
Arrowfly launches MDO Medtech Innovation Board to empower medical device industry acceleration through collaboration PR Newswire
Narlabs STPI Unveils "MEDPilot" AI System to Streamline U.S. FDA Medical Device Submissions ibmi.taiwan-healthcare.org
BMC Launches 100-Day Campaign to Boost ABHA Registrations, Digital Health Services in Mumbai Digital Health News
Medicare National Coverage Determination 190.20 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare National Coverage Determination 190.19 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare National Coverage Determination 190.18 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare National Coverage Determination 190.17 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare National Coverage Determination 190.16 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare National Coverage Determination 190.15 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare National Coverage Determination 190.14 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare National Coverage Determination 190.13 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Medicare National Coverage Determination 190.12 (NCD).
→ Coverage decision — check reimbursement / formulary impact for your patients.
Item(s): Reg FD, exhibits
The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.
IMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential elevated endotoxin levels.
→ Recall issued — check whether you stock the affected product.
Premiums are stable, but Medicare Advantage plans are making big changes that could make care more expensive for patients.
"Highlighting a ton of open questions": Top journal's special issue on women's health examines the latest discoveries on chronic pain and menopause.
Why have so many Americans lost trust in science? And what's the deal with a new gene-editing lawsuit? Find out on this week's episode of "The Readout LOUD" podcast.
Proposed changes to the federal government’s health survey would undercount Americans with disabilities, advocates say.
Chinese-designed drugs now account for roughly half the global pipeline. STAT's Jason Mast traveled to Shanghai to get an up-close look at the competition that's making American's nervous.
Health care companies dominate the MAHA Summit, and a look at Trump's watered down effort to lower Medicare drug prices.
In this edition of STAT Health Tech: A California insurer on how it may replicate Medicare's tech-enabled chronic-care experiment.
A final Medicare rule aimed at lowering prices for doctor-administered drugs applies to only four companies and saves 96% less than the initial proposal
Eli Lilly impressed with its amylin-Zepbound combination data. Elsewhere, Novo demonstrated continued weight loss following a switch to oral and AbbVie and Boehringer gave glimpses into their contenders.
The deal carries a $1 billion upfront payment and tasks the two companies to develop long-acting antibody drugs that go after the same targets as their blockbuster anti-inflammation agent.
The department is offering funding to teams with innovative proposals as it considers ending the traditional phased clinical trial system.
The innovation challenge is focused on developing home devices that could help reduce hospital readmissions.
Medtronic plans to study the device in patients with peripheral artery disease below the knee, a historically difficult condition to treat.
The regulatory authorizations come as Medtronic looks to differentiate itself in the fast-growing pulsed field ablation market targeted by rivals Abbott, Boston Scientific and J&J.
Ten pharmaceutical companies will start paying after-the-fact rebates instead of upfront discounts on 21 drugs in 340B at the start of next year, more than in the Trump administration’s first attempt at a rebate program.
Although artificial intelligence has quickly become integrated into Americans’ daily lives, patients say they’re becoming increasingly concerned about their health data, according to a new survey.
A Leerink Partners analysis of Medicare Plan Finder shows how the largest MA carriers are cutting dental allowances and premium givebacks next year as they continue to prioritize margin recovery.
The AMA found that OptumRx, Express Scripts, CVS Caremark and Prime Therapeutics controlled 75% of the national PBM market in 2024. The post AMA: PBM Market Concentration Is On the Rise appeared first on MedCity News .
Sanofi and Regeneron Pharmaceuticals will collaborate on four next-generation antibody drugs that could offer advantages over Dupixent, the blockbuster immunology drug spawned by their R&D alliance. The companies project these drugs will start reaching pivotal testing in 2029 — important because Dupixent faces patent expiration in 2031. The post Sanofi Puts Up $1B to Expand Regeneron Alliance a
Why more than 300,000 missing patient records reveal an engineering problem, not a policy one — and why that’s good news. The post The Real Gap in All of Us Isn’t Consent, It’s Conversion appeared first on MedCity News .
Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings…
Mid-year report 2026 from the Executive DirectorEMA presented results and achievements of its operations for the first half of 2026 to the Management Board. Between January and…
This report describes a case of fatal pneumonic plague reported in Arizona during 2025.
→ New FDA guidance — may shift practice or documentation expectations.
This report describes mystery patient drills conducted in health care facilities in New Jersey, New York, and the U.S. Virgin Islands to simulate response to an infectious disease outbreak.
→ New FDA guidance — may shift practice or documentation expectations.
Bayesian Health's FDA-Cleared Continuous AI Sepsis Monitor Approved for Medicare New Technology Add-on Payment (NTAP) Memorial Care Innovation Fund
Mavacamten gains FDA approval for symptomatic obstructive HCM in pediatric and adult patients Cardiovascular Business
how long has zepbound been fda approved polskieradio.pl
Axogen Completes Acquisition of BioCircuit Technologies, Adding NerveTape™, the First FDA Cleared Device for Sutureless Peripheral Nerve Repair The Manila Times
fda approved peptides for weight loss polskieradio.pl
This FDA-Cleared Hair Gadget Is the Way to Fuller Locks - and on sale now at Walmart! tag24.com
Wristband as Medical Device: How Femtech Earned Its Clinical Credentials Foley Hoag
FDA approves Cedarville medical device for neck injuries Yahoo
SkinnyVIP Launches Real-Price Index Tracking Published GLP-1 Telehealth Pricing Yahoo Finance
Direxion and Direxion HI-FLO Microcatheters. Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
CareIntellect Perinatal . Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
Medline Convenience Kits Containing Cannula Components with Female Luer Lock Connectors. Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
Radiography 7000 M. Performance
→ Class II recall — verify affected lots; temporary or reversible risk.
The pharma giant cut its partnership after a cancer drug disappointed in testing. Elsewhere, Teva and Samsung Bioepis expanded a partnership and space biotech Varda brought in $251 million.
Detailed results are competitive with Dupixent and Ebglyss, but the drug lacks differentiation amid an increasingly competitive landscape, one analyst argued.
Edwards Wins FDA Approval for Pediatric, Size-Adjustable Pulmonary Valve Medical Product Outsourcing
Atara, Pierre Fabre take third shot at FDA approval of Ebvallo BioWorld News
fda approval mounjaro for weight loss polskieradio.pl
BMS wins US FDA approval to expand CAMZYOS to paediatric patients with obstructive HCM Dealroom
SkinnyVIP Launches Real-Price Index Tracking Published GLP-1 Telehealth Pricing The Manila Times
FDA application NDA218550 approved. ROZLYTREK ENTRECTINIB
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA219617 approved.
→ Newly FDA-approved — consider where it fits among current options.
Public Health Data & Maternal Mortality Data Concerns Grow Telehealth.org
FDA application ANDA210341 approved. CARBIDOPA AND LEVODOPA CARBIDOPA, CARBIDOPA AND LEVODOPA CARBIDOPA. Class: Aromatic Amino Acid [EPC], Aromatic Amino Acid Decarboxylation Inhibitor [EPC], DOPA Decarboxylase Inhibitors [MoA]
→ Newly FDA-approved — consider where it fits among current options.
fda-approved weight loss drugs telehealth new jersey 2025 www.polskieradio.pl
FDA application ANDA201588 approved. OLANZAPINE OLANZAPINE. Class: Atypical Antipsychotic [EPC]
→ Newly FDA-approved — consider where it fits among current options.
PMS-FAMPRIDINE . Contamination
→ Class II recall — verify affected lots; temporary or reversible risk.
Results posted 2026-09-30. Condition: Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides. This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back or tha
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Breast Cancer. The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started . Sponsor: Pfizer. Status: ACTIVE_NOT_RECRUITING. Phase: Phase 1, P
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: HIV, HIV Testing, Women, Contingency Management. African American and Latina women, as well as women living in poverty, are an identified health disparities population for HIV. Risks for HIV are compounded in this population when additional risk factors are present, including other sexually transmitted infections, intimate part. Sponsor: UConn Health. Status:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Recurrent Anaplastic Large Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Classic Hodgkin Lymphoma, Recurrent Mycosis Fungoides. This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer \[NK\] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patient
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Depression, Anxiety, Adolescent Behavior, HIV Infections. This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV c. Sponsor: University of
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Osteoporosis. Osteoporosis (severe bone loss) is a bone disease with bone fragility and an increased chance for bone fractures. Recent studies have indicated tocotrienols (one kind of vitamin E) supplement may be good for the bone health in postmenopausal women. However, no study has ever been. Sponsor: Texas Tech University Health Sciences Center. Status: COM
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Soft Tissue Injuries. A multi-center, prospective, open-label, controlled study of the pharmacokinetics and safety of the LicartTM topical system in pediatric and adult participants with minor soft tissue injuries. 150 male and female participants aged 6-16 and 18-45 with soft tissue injuries meeting . Sponsor: IBSA Institut Biochimique SA. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Type 2 Diabetes Mellitus. The subjects of this study are patients with type 2 diabetes mellitus. The patients take part in dietetic therapy and exercise therapy, and also receive diabetes education to improve lifestyle habits, but since diet and exercise are lifestyle-based, it is generally difficult to m. Sponsor: Astellas Pharma Inc. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Dyspareunia. Randomized, double-blind, placebo-controlled, parallel-designed, multiple-site, bioequivalence study with clinical endpoints.. Sponsor: Teva Pharmaceuticals USA. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Von Willebrand Disease. To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures.. Sponsor: Grifols Biologicals, LLC. Status: TERMINATED. Phase: Phase 4.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Primary Immunodeficiency Diseases (PID). The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older. The participants will be trea. Sponsor: Takeda. Status: COMPLETED. Pha
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Inflammatory Bowel Diseases. The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied a. Sponsor: Terrence A Barrett. Status: COMPLETED. Pha
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), Metastatic Cutaneous Melanoma (Stage IV). The goal of this clinical trial is to learn about the effectiveness and safety of the bispecific antibody acasunlimab (also known as DuoBody®-PD-L1x4-1BB) when given either alone or together with the cancer drug
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Low Back Pain. This is a NIAMS-sponsored clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. This is a single-arm controlled trial with individuals aged 18-70 with low back pain (LBP). This study in. Sponsor: Boston University Charles River Campus. Status: COMPLETE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Hyperinsulinemia, Insulin Resistance, Non-Alcoholic Fatty Liver Disease, Prediabetic State. The goal of this clinical trial is to compare a two-week course of diazoxide (at two different doses) and placebo in people with overweight/obesity and insulin resistance (IR) with, or at high risk for, non-alcoholic fatty liver disease (NAFLD). The main questions it ai
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: CBD, Transplant Complication, Kidney Disease, Chronic. The information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.. Sponsor: Indiana University. Status: COMPLETED. Phase: Phase 1.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Transplant. The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).. Sponsor: Icahn School of Medicine at Mount Sinai. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Anxiety, Depression, Coping Skills, Emotional Problem. This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separation/divorce. Reappraisal, distraction, and relaxation coping strategies are related to f. Sponsor: Arizona State Un
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Amyotrophic Lateral Sclerosis. The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.. Sponsor: AL-S Pharma. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Anxiety, Insomnia, Benzodiazepine, Deprescription. The main purpose of this 12-week study is to see if a new combination of treatments can help older adults reduce benzodiazepine or related medication use. The treatment combination consists of 1) medical provider visits to gradually reduce the medication dose over 12 weeks, 2) ac. Sponsor: Vanderbilt Universit
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-30. Condition: Fragile X Syndrome. This is a single dose, placebo-controlled study. Male subjects aged 18 to 40 years (inclusive) with a diagnosis of FXS. Eligible subjects may enroll in this study comprised of two in home and two in clinic visits each 14 days apart, for a total of four visits. Subjects will be gi. Sponsor: Craig Erickson. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Rule. The Food and Drug Administration (FDA) is classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the flushing and storage solution for vascular autografts at room temperature. We ar
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA, Agency, or we) has determined that ISTURISA (osilodrostat) tablets, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for osilodrostat tablets, 10 mg if all other legal and regulatory requirements are met.
→ New FDA guidance — may shift practice or documentation expectations.
Item(s): leadership change, Reg FD, exhibits
Item(s): Reg FD, exhibits
Pennsylvania officials count four measles-related deaths this year. The CDC only counts two.
“The surest way to secure our biotech lead is to build up our own capabilities,” write Gary Locke and Patrick McHenry.
Kratom has skirted regulation for decades, but newer, highly concentrated 7-OH products have renewed interest in safeguards.
New research involving giving mice a human cell-based cortex brings to mind “Flowers for Algernon” and “Pinky and the Brain,” writes STAT Lab Dish columnist Paul Knoepfler.
By the end of 2026, EMA will develop a regulatory roadmap to help drive decisive change on how women’s health is considered across medicines development and regulation. This…, Women are still missing: from research and data, prevention, diagnosis and treatment. But the momentum to improve support for women’s health has never been stronger.…, Meaningful change starts with dialogue a
Item(s): leadership change
Item(s): Reg FD, exhibits
The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health.
WASHINGTON — The Trump administration published a final rule aimed at lowering Medicare prices for drugs administered in doctor offices. It applies to only four companies. The Global Benchmark for…
An investor lawsuit against UnitedHealth Group will move forward after a federal judge declined the company’s motion to dismiss allegations.
Federal health officials want to speed up clinical research to compete with countries like China.
Hundreds of thousands of immigrants with legal status, including refugees and sex-trafficking victims, are at risk of losing government health coverage starting Oct. 1.
In this edition of AI Prognosis: Dispatches from Health Datapalooza and MAHA Institute Open Data Summit, and other health AI news.
An investigational combination therapy from Eli Lilly led to significant weight loss in a mid-stage study, but high discontinuation rates raise questions about tolerability.
About half of rural voters identify with MAHA movement, but most said President Trump’s health care policies have not benefited their communities, according to a new poll.
Beam Therapeutics has filed a lawsuit alleging one of its former scientists stole intellectual property and used it to co-found a Chinese company that recently made a deal with prominent VC…
Gene-editing company Beam Therapeutics is alleging that one of its scientists stole intellectual property and used it to co-found a Chinese company
A spokesperson confirmed that a “limited number” of liver-related safety events, including a patient death, were observed in testing of Bristol Myers’ admilparant — though it’s unclear whether the drug was to blame.
The FDA previously hadn’t ever accepted an application of a drug like fenebrutinib in two major forms of MS. But safety questions still hang over Roche’s program.
A former congressman will take over for prominent lobbyist Steve Ubl. Elsewhere, recent buyout deals paid dividends for Mirum and AbbVie.
Abbott will sell Freenome’s SimpleScreen CRC test in the U.S. alongside the Cologuard Plus stool-based test it gained in the $21 billion acquisition of Exact Sciences.
The board has proposed lower tariffs on U.S.-bound household goods and toys, but the White House did not specify reduction amounts or an implementation date.
Rodolphe Katra has joined from Medtronic to lead GE HealthCare’s efforts to connect devices, software and data.
The insurer said it’s trying to restrict hospitals from charging higher rates for services at off-campus outpatient departments. Hospital groups say the reimbursement cuts could threaten access to care.
Three major health system mergers have been proposed in the state over the past six months, kicking off a rush of public hearings and regulatory reviews. Essentia and HealthPartners hope to close their deal early next year.
The FDA is recruiting to fill vacancies on its advisory committees, informally known as adcomms. While these committees have met less frequently during the Trump administration, more meetings have been scheduled since former Commissioner Marty Makary left the agency in May. The post FDA Looks to Bring New Scientific, Consumer Voices to Advisory Committees appeared first on MedCity News .
In this episode, we’re joined by Claire Love, deals strategy principal at PwC. We discuss PwC’s recent report showing the opportunities in the fertility and reproductive health market. The post MedCity FemFwd: Opportunities in the Fertility Market appeared first on MedCity News .
Health tech companies made several major funding announcements in September. Here is a list of some of the biggest funding rounds. The post 4 Notable Health Tech Funding Announcements in September appeared first on MedCity News .
For one ICU physician and startup CMO, the more immediate danger isn’t an autonomous system taking over medicine and leaving human decision-making behind. It’s healthcare organizations harnessing AI primarily to increase efficiency while leaving healthcare providers even more mired in complexity and regulation. The post AI’s Healthcare ‘Doomsday’? It May Be Less About Autonomy Than Trust appea
AI could play a meaningful role in advancing social care. Not by replacing people, but by helping them and organizations doing this work move faster, see patterns earlier, and coordinate more effectively. The post AI Won’t Fix Social Care, But Could It Help Us Finally Make It Work? appeared first on MedCity News .
Medtronic (MDT) Gets FDA Clearance For LigaSure RAS Device In The U.S. Yahoo Finance
Vein Closure Device Receives FDA Clearance www.dicardiology.com
Siemens Healthineers Launches FDA-Cleared D-Dimer Blood Test Clinical Lab Products
$11.18 Million DARPA Award Ignites a Major New Catalyst as FDA, Robotic TMS and Commercialization Milestones Converge for NRx Pharmaceuticals, Inc FinancialContent
Idea to Industry: Built to Clear FDA: A Prototyping Framework That Works Johns Hopkins University
Fetch Pet Insurance Launches Telehealth Service todaysveterinarybusiness.com
The company will focus on automating and modernizing processes, better managing suppliers, partners and vendors and making employees more efficient, executives said during a Wednesday investor day.
FDA application NDA020766 approved. XENICAL ORLISTAT. Class: Intestinal Lipase Inhibitor [EPC], Lipase Inhibitors [MoA]
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA213702 approved. ZEPZELCA LURBINECTEDIN
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA214998 approved. CAMZYOS MAVACAMTEN, CAMZYOS MAVACAMTEN, CAMZYOS MAVACAMTEN. Class: Cardiac Myosin Inhibitor [EPC], Cardiac Myosin Inhibitors [MoA]
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA218875 approved. ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA218023 approved. ACETAZOLAMIDE ACETAZOLAMIDE, ACETAZOLAMIDE ACETAZOLAMIDE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA040263 approved. METHOTREXATE SODIUM METHOTREXATE SODIUM, METHOTREXATE SODIUM METHOTREXATE SODIUM
→ Newly FDA-approved — consider where it fits among current options.
FDA application NDA016785 approved. MATULANE PROCARBAZINE HYDROCHLORIDE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA202139 approved. INDOMETHACIN INDOMETHACIN
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA220181 approved. LEVOCARNITINE LEVOCARNITINE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA219175 approved. PHYTONADIONE PHYTONADIONE
→ Newly FDA-approved — consider where it fits among current options.
FDA application ANDA220722 approved. LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE
→ Newly FDA-approved — consider where it fits among current options.
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton). Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1. Class II Reason: Defective Delivery System: Possibility of no medication in the prefilled pen.
→ Class II recall — verify affected lots; temporary or reversible risk.
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.. Class III Reason: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
→ Class III recall — unlikely to cause harm; low urgency.
Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15.. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China. Class II Reason: cGMP Deviations
→ Class II recall — verify affected lots; temporary or reversible risk.
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.. Class II Reason: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
→ Class II recall — verify affected lots; temporary or reversible risk.
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.. Class II Reason: Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.
→ Class II recall — verify affected lots; temporary or reversible risk.
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624. Class II Reason: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
→ Class II recall — verify affected lots; temporary or reversible risk.
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;. Class II Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
→ Class II recall — verify affected lots; temporary or reversible risk.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optic
→ Class II recall — verify affected lots; temporary or reversible risk.
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.. Class I Reason: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment
→ Class I recall — stop use, check your stock, switch to alternatives.
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;. Class II Reason: Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
→ Class II recall — verify affected lots; temporary or reversible risk.
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);. Class II Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
→ Class II recall — verify affected lots; temporary or reversible risk.
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R. Class II Reason: Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
→ Class II recall — verify affected lots; temporary or reversible risk.
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811. Class II Reason: The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibio
→ Class II recall — verify affected lots; temporary or reversible risk.
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);. Class II Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
→ Class II recall — verify affected lots; temporary or reversible risk.
MR 5300 Model Number (REF): 1. 782110, 2. 782152;. Class II Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
→ Class II recall — verify affected lots; temporary or reversible risk.
Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;. Class II Reason: Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
→ Class II recall — verify affected lots; temporary or reversible risk.
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.. Class II Reason: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
→ Class II recall — verify affected lots; temporary or reversible risk.
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);. Class II Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconst
→ Class II recall — verify affected lots; temporary or reversible risk.
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.. Class II Reason: Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
→ Class II recall — verify affected lots; temporary or reversible risk.
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF, Catalog Number: DYNJ04342M; 6) LAMINECTOMY PACK-LF, Catalog Number: DYNJ43218G; 7) CRANIOTOMY PACK, Catalog Number:
→ Class II recall — verify affected lots; temporary or reversible risk.
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye. Class II Reason: Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Fallin
→ Class II recall — verify affected lots; temporary or reversible risk.
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve. Class II Reason: Labeling; Oxygen Cylinders do not contain required medical gas labeling
→ Class II recall — verify affected lots; temporary or reversible risk.
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.. Class II Reason: Gowns do not consistently meet the minimum liquid-barrier performance required.
→ Class II recall — verify affected lots; temporary or reversible risk.
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.. Class I Reason: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
→ Class I recall — stop use, check your stock, switch to alternatives.
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series. Class II Reason: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
→ Class II recall — verify affected lots; temporary or reversible risk.
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;. Class II Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
→ Class II recall — verify affected lots; temporary or reversible risk.
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A14. Class II Reason: There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do
→ Class II recall — verify affected lots; temporary or reversible risk.
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.. Class II Reason: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
→ Class II recall — verify affected lots; temporary or reversible risk.
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number: IVS3223531; 5) KIT, IV SUPPLIES , Catalog Number: IVS3223532; 6) KIT, IV SUPPLIES , Catalog Num
→ Class II recall — verify affected lots; temporary or reversible risk.
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101
→ Class I recall — stop use, check your stock, switch to alternatives.
Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day. Class II Reason: A small number of lenses within the affected lot are of the incorrect power.
→ Class II recall — verify affected lots; temporary or reversible risk.
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver. Class II Reason: Labeling; Oxygen Cylinders do not contain required medical gas labeling
→ Class II recall — verify affected lots; temporary or reversible risk.
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);. Class II Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
→ Class II recall — verify affected lots; temporary or reversible risk.
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;. Class II Reason: The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
→ Class II recall — verify affected lots; temporary or reversible risk.
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15. Class II Reason: The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could resu
→ Class II recall — verify affected lots; temporary or reversible risk.
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);. Class II Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
→ Class II recall — verify affected lots; temporary or reversible risk.
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.. Class II Reason: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
→ Class II recall — verify affected lots; temporary or reversible risk.
Elsevier launches ClinicalKey Nursing AI, a new evidenced-based clinical AI solution built specifically for nurses WebWire
Results posted 2026-09-29. Condition: Speech, Consolidation. These studies test the hypothesis that sensory areas of the brain participate in the consolidation of speech motor memory by using transcranial magnetic stimulation to suppress activity in somatosensory and auditory cortex following adaptation in order to block retention of learn. Sponsor: Yale University. Status: TERMINATED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: SLE; Drug. The clinical trial is titled "A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients with Systemic Lupus Erythematosus". This study was designed to address the following key questions: * Phase 1b: . Sponsor: Kangpu Biopharmaceuticals, Ltd.. Status: COMPLETED. Phase: P
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: High Grade Myelodysplastic Syndromes. This study will treat patients with previously untreated high grade myleodysplastic syndromes (MDS) with both omacetaxine mepesuccinate and azacitidine.. Sponsor: University of Colorado, Denver. Status: ACTIVE_NOT_RECRUITING. Phase: Phase 1, Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: HER2 Positive Breast Cancer. This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects h. Sponsor: Seagen, a wholly owned subsidiary of Pfize
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer. Previous studies of high dose testosterone therapy given intramuscularly to men with metastatic castrate resistant prostate cancer suggest that high serum levels of testosterone may be required for clinical response. This injection regimen was given as one d
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Dietary Behavior. The goal of this study is to determine the feasibility and acceptability of two food preference learning approaches for toddlers that could serve as alternatives to mere repeated exposure to new or previously disliked foods. The target population is toddlers who score higher on f. Sponsor: State University of New York at Buffalo. Status: COMP
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Unresectable Hepatocellular Carcinoma. This phase II trial tests whether 68-Gallium prostate specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) imaging can improve the diagnosis and management of liver cancer that has
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Healthy Volunteers. This study is a Phase I, open-label, single-centre, randomised, two-period, single-dose crossover study to compare and assess the bioequivalence, safety, tolerability and pharmacokinetics of hydroxycarbamide dispersible tablets (20 x 50 mg) (test IMP) and hydroxycarbamide film-co. Sponsor: Theravia. Status: COMPLETED. Phase: Phase 1.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Brain Metastases. This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body). Sponsor: Brigham and Women's Hospital. Status: ACTIVE_NOT_RECRUITING. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Geriatric Cancer Patients. In this prospective quality improvement study, we will develop and evaluate the feasibility and acceptability of an online patient self-reported G8 screening tool which will allow us to efficiently identify G8 positive older cancer patients to be referred to our Senior Adult Onco. Sponsor: Thomas Jefferson University. Status: COMPLET
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Type 2 Diabetes, Food Insecurity. This is a pragmatic randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). This pragmatic RCT will leverage Project Open Hand's (POH) real-world programs to test the impact of a six month medically tailored food support and nutrition in. Sponsor: University of California, San Francis
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Gynecologic Cancer, Sexual Dysfunction. The purpose of this research study is to investigate the use of pelvic physical therapy for gynecologic cancer survivors who report sexual dysfunction. Physical therapy experts believe that a full 10-week regimen is necessary for true improvement of symptoms. Investigators aim to. Sponsor: Wake Forest University Health S
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Chronic Disease. The purpose of this study is to figure out the best way to help veterans do advance care planning. This study will examine the effects of two theory based behavior interventions by randomizing veteran into 4 groups to see which veterans will complete the 4 step process of advance. Sponsor: VA Connecticut Healthcare System. Status: COMPLETED. P
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Relapsed or Refractory Multiple Myeloma. The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myelom. Sponsor: Hoffmann-La Roche. Status: TER
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Schizophrenia. This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.. Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.. Status: TERMINATED. Phase: Phase 2, Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Takotsubo Cardiomyopathy. The goals of this study are as follows: 1. To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS). 2. To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event. Sponsor: The Miriam Hospital. Status: COMPLETED. Phase
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Diabetes Mellitus. The aim of the proposed clinical trial is to study the use of the Dexcom G7 continuous glucose monitor (CGM) within the intensive care unit (ICU) environment. The overall goal is to validate the accuracy and practicality of the Dexcom G7 when used to assess glycemia in critically. Sponsor: University of Massachusetts, Worcester. Status: COMP
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Heart Transplant. The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking toci. Sponsor: National Institute of Allergy and Infectious Diseases
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Type 2 Diabetes. To test whether a lifestyle program featuring one of two forms of intermittent fasting (IER or TRE) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.. Sponsor: University of Kansas Medical Center. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Cancer, Neoplasm. The study enrolled advanced cancer participants with unresectable or metastatic disease who were refractory to or were not candidates for standard approved therapy. The study comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2. Sponsor: Sanofi. Status: TERMINATED. Phase: Phase 1, Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Amyotrophic Lateral Sclerosis, ALS. This is a clinical trial to evaluate the safety, tolerability, and biological effect of LAM-002A in adults with C9ORF72-associated ALS (C9ALS).. Sponsor: OrphAI Therapeutics. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Acute Alcoholic Hepatitis, Chemical and Drug Induced Liver Injury, Alcohol-Induced Disorders, Steatohepatitis Caused by Ingestible Alcohol. Prospective, single center, open label, randomized controlled trial to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients with acute alcohol associated hepatitis, digoxin ad
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-09-29. Condition: Carcinoma, Hepatocellular. Open-label, uncontrolled, Phase 1-2 study to evaluate the safety, tolerability, pharmacodynamic effects, and preliminary efficacy of ABX196 administered in combination with nivolumab in patients with hepatocellular carcinoma. Sponsor: Abivax S.A.. Status: COMPLETED. Phase: Phase 1, Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
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Health technology beyond the journals: digital health and clinical AI, remote monitoring and wearables, health IT, and the device launches, deals, and products reshaping how care is delivered. Curated from healthtech and industry press.
Bottom line. This cycle's healthtech-relevant signal is thin: the one item worth watching is a direct-to-consumer AI breast-cancer risk tool bypassing clinician and payer channels, which raises real questions about validation, counseling, and downstream harms.
No healthtech items match that search.
Roche has inked a drug discovery deal with Chinese biotech Defand Therapeutics, focused on molecular glue medicines.
All six Nobel awardees in physiology or medicine, physics, and chemistry this year were men. Women make up 4% of laureates since the award’s inception.
Smaller biotech firms are trying to figure out how to win exemptions from Trump's import taxes.
Power House health committees could get a lot of new members after the midterms.
“A small, well-intended discount for safety net hospitals became a large institutional subsidy with expensive unintended consequences,” writes an HHS leader.
Eliminating hepatitis C is achievable — if the U.S. seriously invests in it, experts write.
A startup didn't want to wait for doctors and insurers to get behind its breast-cancer risk prediction AI. So it's going directly to patients.
There’s increasing evidence that older women with breast cancer could benefit from more tailored treatments. STAT Wunderkind Neil Carleton is working to make that a reality.
“Don’t google,” the pediatric geneticist warned. It took me five years to disobey.
FDA Approval of Daraxonrasib Marks Turning Point in Pancreatic Cancer Care Bioengineer.org
Sonorous wins FDA IDE for pulsatile tinnitus stent pivotal trial initiation Medical Device Network
FDA medical device recall system undercounts AEs Medical Buyer
IQVIA Launches Life Science Models to Predict Clinical Trial Outcomes Voice of Healthcare
The Justice Department issued a new directive for combating fraud that noted the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry.
A new study found that visits by people born outside of the U.S. to three LA emergency rooms dropped precipitously after ICE raids increased last year.
Henri B. Kagan and Kenso Soai were awarded the 2026 Nobel Prize in chemistry on Wednesday for solving a mystery with research on "mirror image" molecules.
Caribou Biosciences is shutting down after failing to raise the money necessary to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma.
Exon-skipping drugs present a critical test for the FDA’s goal of encouraging treatments for rare disease.
Key Democrats are meeting with MAHA activists and rolling out food and environmental plans to entice them.
“I reject the idea that a man who keeps every prostate cancer surveillance appointment has ‘untreated cancer,’” writes Howard Wolinsky.
Cerevance plans to meet with the FDA to “determine next steps” for a new kind of medicine known as solengepras, now that it has Phase 3 data in hand.
The company has integrated artificial intelligence scribing and camera-based vitals monitoring into its virtual care platform for hospitals as it works to recover from significant financial setbacks.
New FDA-Approved Treatment Offers Another Option for Adults With Fibromyalgia NBC Palm Springs
HeartSciences gets FDA clearance for MyoVista wavECG Mugglehead Investment Magazine
CurveBeam AI (ASX:CVB) FDA Clearance Raises the Stakes for Its Imaging Expansion Kalkine
Digital Health Networks launches pharmacy council Home | Digital Health
FDA Advisory No.2026-1507 || Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “UNBRANDED ARM SLING https://www.fda.gov.ph/
FDA Advisory No.2026-1506 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “HUAKUN BV FILTER” https://www.fda.gov.ph/
About half of the patients in a study regained photosensitivity in their vision, showing the promise of optogenetics.
The Trump administration has proposed a $70,000 fee for a popular work authorization program meant to give students professional experience
The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.
In a setback for Merck, a Dutch court ordered a halt to the manufacturing and marketing of a subcutaneous formulation of Keytruda in several European countries.
Forbion, a prominent European venture capital firm, said it has raised $2.6 billion, its largest fundraise to date and one of the largest in the region in recent years.
In this edition of STAT's AIP Prognosis: Unresolved regulatory questions around Utah's AI sandbox, and more health AI news.
The World Health Organization released its first guidelines addressing the sharp rise in obesity among children and adolescents
Despite having an allogeneic cell therapy prospect that’s ready for late-stage testing in lymphoma, Caribou couldn’t secure funding to support the effort and will now pursue “strategic alternatives” instead.
A Dutch court barred Merck from selling subcutaneous Keytruda in several European countries. Elsewhere, an Insmed executive ended a seven-year run and two startups secured venture cash.
Kurz’s appointment comes as Medtronic enjoys strong growth in electrophysiology therapies thanks to demand for its pulsed field ablation devices.
The Medicines and Healthcare Products Regulatory Agency adopted 44 recommendations, including a call for AI-enabled devices to be monitored throughout their working life.
Patients can view their pulmonary artery pressure readings on their phone with the CardioMEMS updates, giving them a more active role in their care.
Bottom line. Regeneron and BioMarin posted clinical results that carry direct prescribing relevance; Ultragenyx struck a material agreement that could affect rare-disease drug access. Most other filings are leadership or administrative events with no immediate bedside impact.
The makers behind the drugs and devices you follow — their SEC filings (deals, recalls, supply, leadership) shown next to their approvals, clearances, recalls, and trials on the wire. Search a maker to see its full timeline.
Pick a company to see its filing timeline, or search above.
New and recent clinical trials, grouped by specialty — what's entering the pipeline for your patients, who's running it, and how far along it is.
Bottom line. A mixed batch of phase II oncology, rare-disease, ophthalmology, and vaccine readouts posted simultaneously; most are hypothesis-generating or confirmatory at best, and none alone is immediately practice-changing without seeing full result data.
No trials match that search.
A quick rating helps shape what comes next.