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.
Regulatory briefingUpdated today · patient-safety items first
Bottom line. Multiple critical IV drug shortages (dobutamine, sodium bicarbonate, meperidine discontinued) and two particulate-matter recalls (cyclophosphamide, cefazolin) demand immediate pharmacy review and contingency planning. A Boston Scientific carotid neuroprotection catheter tip-separation alert requires urgent procedural hold assessment.
PATIENT SAFETY: Recalls and Device Alerts
Boston Scientific ENROUTE Transcarotid Neuroprotection System: arterial sheath tip may separate during transcarotid arterial revascularization procedures.So what: Hold use pending institutional review; tip separation risks distal embolism or vascular injury during TCAR procedures.
Sunny Pharmtech recalls three lots of Cyclophosphamide for Injection (1g and 2g vials) due to visible particulate matter.So what: Pull and quarantine affected lots immediately; verify alternative supply before scheduling chemotherapy infusions.
Baxter recalls one lot of Cefazolin in Dextrose Injection 2g/100mL (Lot LD175708, exp Feb 2027) for particulate matter in solution.So what: Quarantine Lot LD175708; inspect remaining cefazolin premix inventory given ongoing surgical prophylaxis reliance.
MHRA Class 4 defect: Neuraxpharm Tuzulby prolonged-release chewable tablets missing safety information in patient leaflet and SmPC (UK).So what: UK prescribers should provide missing safety counseling verbally until corrected labeling is distributed; not a US market issue.
Health Canada recalls HeartSine Samaritan PAD SAM 350P/360P/500P for membrane tail performance and labeling issues (two separate notices).So what: Inspect and remove affected AED units from crash carts and public locations in Canada; verify replacement availability.
Health Canada recalls Shimadzu X-ray High Voltage Generators for performance issues.So what: Canadian sites should suspend affected units and arrange service inspection before resuming diagnostic imaging.
Health Canada recalls Philips Achieva and Ingenia MRI systems for performance issues.So what: Canadian sites should verify affected system serial numbers with Philips and follow field correction instructions before scanning.
PATIENT SAFETY: Critical Drug Shortages
Dobutamine HCl Injection is now unavailable (cardiovascular, pediatric, renal indications); reason listed as other.So what: Identify milrinone or alternative inotrope protocols now; coordinate with pharmacy and cardiology before next cardiogenic shock case.
Sodium Bicarbonate Injection is unavailable due to manufacturing discontinuation; affects endocrinology, GI, and pediatric care.So what: Alert ICU, ED, and NICU teams; pre-position remaining stock for life-threatening acidosis and establish conservation protocols.
Meperidine HCl Injection is unavailable due to manufacturer discontinuation.So what: Transition all meperidine orders to alternative analgesics; update order sets and counsel staff on substitution protocols.
Lorazepam Injection has limited availability due to demand increase (neurology).So what: Prioritize remaining stock for status epilepticus and procedural sedation; consider diazepam or midazolam as substitutes.
Belladonna and Opium Suppository is newly listed as a shortage (analgesia).So what: Identify alternative analgesic/antispasmodic options for urology and palliative patients who rely on this formulation.
Heparin Sodium Injection and Dexmedetomidine HCl Injection are now available again after prior shortage listings.So what: Confirm resupply through pharmacy; update any conservation restrictions that were placed during prior shortage periods.
FDA Drug Approvals
FDA approved RINVOQ LQ (upadacitinib) liquid formulation (NDA218347), a JAK inhibitor, on 2026-08-19.So what: Liquid formulation expands upadacitinib to patients unable to swallow tablets, such as pediatric or dysphagic populations; JAK inhibitor safety monitoring still required.
EMA Opinions (EU Approvals Pending EC Decision)
EMA positive opinion for Zokovea (ensitrelvir), an oral antiviral, likely for COVID-19 or similar respiratory viral indication.So what: Not yet approved in US; EU prescribers await European Commission decision before clinical use; monitor label for indication specifics.
EMA positive opinion for Qezzaqar (catequentinib), a targeted oncology agent.So what: Indication details pending EC decision; oncology teams should monitor full label for tumor type and companion diagnostic requirements.
EMA positive opinion for Nezglyal (leriglitazone), a CNS-targeted PPAR-gamma agonist for adrenoleukodystrophy.So what: Rare disease agent; EU neurologists should track EC decision and label for monitoring requirements in adrenoleukodystrophy management.
EMA positive opinion for Meplyffa (arimoclomol), a heat shock protein co-inducer for Niemann-Pick disease type C.So what: Orphan indication; EU rare disease specialists should note EC decision timeline and risk management program requirements.
EMA positive opinion for Lyrokaul (lerodalcibep), an LDL-lowering RNA interference or small molecule agent.So what: Lipid management teams in EU should await EC decision and label to assess role versus statins and PCSK9 inhibitors.
EMA positive opinion for Lynavoy (linerixibat), an IBAT inhibitor for cholestatic pruritus.So what: EU hepatologists should monitor EC decision; linerixibat targets bile acid reabsorption and may benefit PBC or PFIC patients.
EMA positive opinion for KemSu (sufentanil plus ketamine) combination analgesic.So what: Combination opioid-dissociative product; EU anesthesia and pain teams should review label closely for dosing and controlled substance protocols.
Device Classifications (New Class II Rules)
FDA classified active noise attenuation systems for infant incubators as Class II with special controls.So what: NICU procurement teams must verify 510(k) clearance for any new noise attenuation devices before purchasing or using them.
FDA classified non-medicated topical formulations for erectile dysfunction as Class II with special controls.So what: Products in this category now require 510(k) clearance; prescribers should verify regulatory status before recommending specific topical ED devices.
FDA classified intraoperative surgical angle measurement tools as Class II with special controls.So what: OR procurement must confirm 510(k) status for these tools; affects orthopedic and spinal surgical planning workflows.
CMS Coverage Updates
Medicare LCD and billing articles updated for IVIG off-label use, pharmacogenomic testing, botulinum toxin, cervical fusion, MIGS, and urine drug testing.So what: Review updated LCDs for coverage criteria changes before ordering; incorrect coding against new criteria risks claim denial or audit.
Regulatory Pipeline and Administrative
CTGT Advisory Committee meeting notices amended for vusolimogene oderparepvec (BLA 125827) and deramiocel (BLA 125842).So what: Oncology and cardiology teams should monitor advisory committee outcomes; decisions may signal imminent FDA approval or major label conditions.
FDA issued final debarment order against Francis Esteban Matos under the FD&C Act.So what: No direct prescribing impact; confirms FDA enforcement action against a disqualified individual in the drug industry.
Evonik Corporation animal-use food additive petition filed with FDA; OMB review requested for radioactive drug research committee data collection.So what: No immediate clinical practice impact; relevant only to veterinary nutrition and research committee administrators.
Results posted 2026-07-28. Condition: Constipation. Constipation is a very common problem. Western style toilets that are nearly universal in the United States require the person to sit on the toilet. However, results from uncontrolled studies suggests that a squatting posture (as prevalent in many foreign countries) may be better. Sponsor: Mayo Clinic. Status: ACTIVE_NOT_RECRUITING. Phase: Phase
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Cardiovascular Disorder, Coronary Artery Disease, Diabetes Mellitus, Obesity-Related Malignant Neoplasm. This clinical trial develops and tests a culturally-appropriate educational program (Indigenous SIPin) for reducing sugar-sweetened beverage consumption in men affiliated with Native American athletics communities. Sugary drinks are drinks like pop, soda, a
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Influenza. This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax®) versus a licensed co. Sponsor: Duke University. Status: COMPLETED. Phase: Phase 4.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting. The purpose of this study is to better understand the mechanism of action (MoA) of cladribine tablets by exploring the effect on central nervous system (CNS) and blood biomarkers relevant in the relapsing forms of multiple sclerosis (RMS; to include relapsing-remitting MS \[RRMS\. Sponsor: Gregory Wu
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Chronic Kidney Diseases, Bone Loss. The goal of this clinical trial is to test whether potassium citrate improves skeletal health in adults and children with chronic kidney disease. The main questions it aims to answer are:
* To evaluate effects of potassium citrate treatment on bone quality and strength.
* To eva. Sponsor: Albert Einstein College of Medicine
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Accidental Falls, Aging. The objective of this study is to determine if a four-week, 20-session intervention of transcranial direct current stimulation (tDCS), as compared to sham intervention, improves dual task standing and walking performance (Aim 1), as well as other physical (Aim 2) and cognitive (A. Sponsor: Hebrew SeniorLife. Status: COMPLETED. Phase: N
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Vaso-occlusive Crisis, Sickle Cell Anemia Crisis. Sickle cell anemia is a genetic blood disorder where red blood cells are abnormally shaped, crescent- or sickle-shaped, instead of the normal, round shape. This misshapen cell is rigid and sticky, causing them to clump together and block small blood vessels. This blockage can lea. Sponsor: University of Nebrask
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Gram-negative Bacteremia, Bloodstream Infection. This study is a 2-arm, multicenter, multinational, prospective, randomized, controlled clinical trial. Hospitalized subjects with blood cultures growing Gram negative bacilli (GNB) will be randomized 1:1 to have the positive blood cultures characterized using standard of care (SO. Sponsor: Duke University. Statu
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Meniscectomy, Osteoarthritis. The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for perform. Sponsor: Active Implants. Status: COMPLETED. Phase
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Liposomal Bupivacaine. This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine. Sponsor: Case Western Reserve University. Status: COMPLETED. Phase: Phase 4.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8. This phase I/II trial studies the best dose of selumetinib and how well it works with durvalumab and tremelimumab in treating participants with stage IV non-small cell lung cancer or that has come back. Immunotherapy with monoclo
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Diabetic Kidney Disease, Hyperuricemia, Diabetes, Diabetes Mellitus, Type 2. Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg/dl. T. Spo
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: NSCLC, Breast Cancer. This is an open-label extension study (Extension Study) designed to allow patients to continue to receive poziotinib treatment who have had previous exposure to poziotinib and/or are still receiving clinical benefit from treatment, as judged by the Investigator or treating physic. Sponsor: Spectrum Pharmaceuticals, Inc. Status: TERMINATED
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Depression. The overall aim of this study is to employ Community Health Workers (CHWs) to screen for depression in 30 Black churches and compare the effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT) (Intervention arm) to Referral As Usual (Control arm) on trea. Sponsor: Columbia University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Multiple Myeloma. This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving mi. Sponsor: University of Michigan Rogel Cancer Center. Status: A
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Stroke. The goal of this clinical trial is to evaluate the impact of a locally adapted stroke unit on outcomes of adults with stroke in Zambia. The main question\[s\] to answer are: • Does provision of evidence-based stroke care improve after implementation of a stroke unit at the Univer. Sponsor: Johns Hopkins University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer. This study is designed as an open-label, adaptive Simon Two-Stage study to evaluate the efficacy of CTX-009 in patients with metastatic colorectal cancer.
A Simon Two-Stage adaptive design will enroll approximately 37 patients into Stage 1, and if criteria are met to move to Sta. Sponsor: Compass Ther
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Cancer Survivor, Dysphagia, Fibrosis, Head and Neck Carcinoma. This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, whi. Sponsor: M.D. And
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Cannabis Use. The Stanford Smart Talk Cannabis Awareness and Prevention Curriculum includes 5 lessons, each providing activities, online quiz games, and worksheets in addition to presentations, resources, and other materials aimed at addressing key factors associated with youth cannabis use, i. Sponsor: Stanford University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Pulmonary Arterial Hypertension. * Evaluate for accuracy and reproducibility of data collected via the participant-operated Walk.Talk.Track. (WTT) app combined with Apple Watch during in-clinic, technician proctored 6MWT's.
* Determine whether the WTT app on the Apple Watch can accurately collect information . Sponsor: Stanford University. Status: COMPLETED
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: HIV. The overall goal of the current study is to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes - alcohol use and HIV - among Young People Living with HIV (YPLWH).. Sponsor: Florida State University. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Type 1 Diabetes Mellitus. This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0. Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing a. Sponsor: National Institute of Allergy and Infectious
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Colorectal Cancer Screening. The goal of this clinical trial it is to bowel the instestinal preparation with lactulose vs poliethylenglicol as better agent to have a quality colonoscopy and demostrate that lactulose is most efective, has a good tolerance and the patient would have a better satisfaction, so t. Sponsor: Hospital Civil de Guadalajara. Status: COM
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-28. Condition: Gastrointestinal Stromal Tumors, Sdh, GIST, Cancer. Funding Source - FDA OOPD
FDA-approved products for patients with unresectable or metastatic GIST include therapies such as imatinib and sunitinib. Although there are FDA-approved products for the treatment of advanced/metastatic GIST, these therapies are known to be ineffective. Sponsor: Adam Burgoyne, MD,
→ New trial — a pipeline signal, not practice-changing yet.
Notice. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of inv
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA, Agency, or we) 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 col
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA) is amending a notice entitled "Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026" that appeared in the Federal Register on September 18, 2025. The notice established the FY 2026 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, mater
→ New FDA guidance — may shift practice or documentation expectations.
One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.
Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.
The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.
Claris Bio has appointed veteran CEO Stephen Brady to lead advanced development of what it hopes to be the first drug therapy for a blinding condition called limbal stem cell deficiency.
Dyne Therapeutics Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for DYNE-302 in Facioscapulohumeral Muscular Dystrophy (FSHD) The Manila Times
“Emergency departments across America report dramatic increases in serious injuries from e-bikes and e-scooters,” write CHOP’s J. Todd R. Lawrence and Madison A. Kesler.
Even as some medical schools heed health secretary Robert F. Kennedy Jr.’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t…
[Sponsored] On a recent webinar sponsored by Verato, panelists from SCAN Health Group and the Alliance of Community Health Plans discussed how their organizations are meeting the moment.
The post AI Readiness Starts with Solving Healthcare’s Data Fragmentation Problem appeared first on MedCity News .
As patients increasingly bring AI chatbot advice into exam rooms, where does liability land when that advice goes wrong? Health law attorney Meghan O’Connor said the answer still isn’t clear, but silence is the riskiest response for providers.
The post What Happens When Patients Trust AI Over Their Doctor? appeared first on MedCity News .
Results posted 2026-07-27. Condition: Induced; Birth. This study aims to develop a visual aid tool for induction education informed by the experiences and needs of historically marginalized pregnant women, as well as determine the impact of the patient-informed visual aid on patient knowledge, satisfaction, and trust in physicians r. Sponsor: Washington University School of Medicine. Status: COMPL
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Obesity, Childhood, Behavior, Health, Healthy Lifestyle. The purpose of this proof-of-concept study is to assess the initial signal of effectiveness of summer youth employment programs (SYEP) on understudied obesity-related outcomes in adolescents. This small-scale study is essential to identify early success and refine the interventio. Sponsor: University of
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Dementia, Alzheimer Disease. This is a validation study to evaluate the acceptability, feasibility and preliminary efficacy of the Brain Health Program, a multimodal curriculum covering dementia risk factors and evidence-based change interventions. The goal of this study is to evaluate the Brain Health Progr. Sponsor: Posit Science Corporation. Status: COMPLET
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Spasmodic Dysphonia. One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment. This initial study was in the context of facial aesthetics. The purpose of the present study is to determine the effect, if any, of or. Sponsor: University of Florida. Status: COMPLETED. Phase: P
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Pain, Chronic, Communication Research, Opioid Use. The overall goal of this protocol is to pilot test a clinician training intervention that uses standardized patients (trained actors playing patient roles) as instructors who impart communication skills to primary care clinicians. This project will conduct a pilot clinical trial . Sponsor: University of Califo
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Trauma-related Wound, Surgical Incision, Surgical Wound, Laceration. The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue Adhesive or Histoacryl® Blue Topical Skin Adhesive wit. Sponsor: So
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Aging. Decline in brain health and associated loss of cognitive function in healthy aging decreases quality of life.We need better tools to both enhance brain health and improve cognitive performance in healthy brain aging so that it can be delayed, reduced, or even reversed. The presen. Sponsor: University of Florida. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Rheumatoid Arthritis. The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).. Sponsor: Alfasigma S.p.A.. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Rheumatoid Arthritis (RA), Arthritis, Rheumatoid (RA). The goal of this clinical trial is to learn if the PREVAIL model of care is a feasible way to integrate rehabilitation into routine rheumatology care for adults with rheumatoid arthritis (RA). The model of care consists of three essential components: a screening tool (Daily Activ. Sponsor: University of No
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Sleep Disturbances, Depression. Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia. Sponsor: Icahn School of Medicine at Mount Sinai. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Chronic Kidney Diseases. Chronic kidney disease (CKD) is associated with a higher risk of cardiovascular disease and death. An overactive sympathetic nervous system in CKD patients is one of the major mechanisms increasing the cardiovascular risks in this patient population. Recently, some studies have s. Sponsor: The University of Texas at Arlington. Status:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Melanoma. The purpose of this research study is to find out whether JX-594 (Pexa-Vec) is safe and effective for treating surgically unresectable malignant melanoma.. Sponsor: Jennerex Biotherapeutics. Status: COMPLETED. Phase: Phase 1, Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Human Immunodeficiency Virus (HIV). The goal of this study is to increase HIV and syphilis testing and linkage to care, increase condom use, and promote PrEP uptake among sexual minority men (SMM) and American Indian (AI) men in rural Oklahoma, a state that is an Ending the HIV Epidemic (EHE) priority state. The pr. Sponsor: Northern Arizona University. Status
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Obesity. A 12-month randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 6-month weight loss period; and (2) 6-month weight maintenance, will be implemented. Adults with obesity will be randomized to 1 of 3 groups: (1) 8h-TRE, ad libitum food intake from 12p. Sponsor: University of Illinois at Chicago. Status: COMPLETED. Phase: N
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Erythropoietic Protoporphyria. The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.. Sponsor: Clinuvel Europe Limited. Status: COMPLETED. Phase: Phase 1, Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-27. Condition: Invasive Breast Cancer. This is a single-arm, open-label, phase 2 study that will enroll 36 subjects, who have pathologically proven diagnosis of invasive breast cancer, clinical stage tumor 1-3 (cT1-T3), node 0-3 (cN0-N3), metastasis 0 (cM0), hormone receptor positive (HR+) (estrogen-receptor-positive . Sponsor: Medical College of Wisconsin. Status: ACTIVE_NO
→ New trial — a pipeline signal, not practice-changing yet.
July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass an
→ Recall issued — check whether you stock the affected product.
The world risks a resurgence of the HIV epidemic after international financing to combat the disease suffered a “profound shock” last year, according to a new report from UNAIDS.
Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
Shares fell more than 66% Monday morning, which analysts suspect is due to investors seeing the data as not competitive with Bristol Myers' Cobenfy.
Capricor shares lost much of their value ahead of a high-stakes advisory committee meeting. Elsewhere, Ying Huang’s resignation extended a stock slide for Legend and AstraZeneca disclosed more pipeline trouble.
Most recently the leader of buzzy startup Tessera Therapeutics, Severino will look to improve the fortunes of a company facing emerging competition and declining sales for its prized gene therapy Elevidys.
Abbott will market Freenome’s SimpleScreen CRC test in the U.S., alongside its Cologuard stool test. SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening.
Aidoc is bringing a system that can interpret images and make draft reports for radiologists to the FDA as the medtech industry awaits clarity on regulation of generative AI. Ensuring safety is paramount, said CEO Elad Walach.
The regional nonprofit and surgical facility operator have co-owned the facilities since 2023. But Surgery Partners, which expects to net almost $800 million from the deal, is looking to reorient its portfolio to a more outpatient-heavy model.
People formerly covered by the ACA exchanges are remaining uninsured almost on a one for one basis. “For us, obviously, it’s not a good thing,” CEO Sam Hazen said.
The hospital operator recorded a $65 million hit from turbulence on the Affordable Care Act exchanges in the second quarter, but avoided the worse repercussions slamming some of its peers.
Lakshmi Halasyamani, chief clinical officer at Endeavor Health, thinks value-based care isn’t really about payment models. To her, this work centers on understanding patients’ clinical, social and financial circumstances well enough to make care plans that actually work for their lives.
The post Why Endeavor Health Refuses to Silo Its Value-Based Care Strategy appeared first on Me
Argenx’s first acquisition is the buyout of Forte Biosciences, a company with a lead drug that has early clinical validation in celiac disease and vitiligo. Argenx executives say this antibody complements its blockbuster product Vyvgart, offering a different mechanism of action but similar pipeline-in-a-product potential.
The post Argenx’s $2B Forte Bio Acquisition Brings Autoimmune Playbook to
When staff are overextended and patients face delays or abandon care, the issue is no longer a narrow administrative burden. It becomes a business, financial, and access challenge that demands a different operating model.
The post Prior Authorization Is Draining Revenue: Why Automation Has Become a Strategic Imperative appeared first on MedCity News .
The question is not whether the technology is impressive. The question is whether it shows up at the right time, with the right information, inside the workflow where the decision is being made. Anything else is just another report.
The post How AI Inside Clinical Workflows Is Unlocking Patient Throughput appeared first on MedCity News .
DifGen Pharmaceuticals Receives FDA Clearance to Begin Clinical Development for a Single Injection treatment for Advanced Breast Cancer DFGN-101 Yahoo Finance
Crystalys’s dotinurad is currently in pivotal testing for gout, a prevalent inflammatory disorder with few treatment options. The drug has the same mechanism of action as a molecule that Sobi added to its pipeline through a $950 million acquisition.
The post Crystalys Therapeutics Tacks On $130M for Pivotal Tests of Gout Drug appeared first on MedCity News .
Candid’s Series D round was led by Sixth Street Growth, with participation from Oak HC/FT, 8VC and Y Combinator.
The post Candid Health Snags $120M for AI RCM Platform appeared first on MedCity News .
VBC aligns reimbursements to outcomes, emphasizing the quality and effectiveness, not quantity, of healthcare activities. But the same cost constraints driving interest in VBC can also turn it into a liability.
The post Why Value-Based Care Only Works If You’ve Tamed Costs appeared first on MedCity News .
A core principle of trauma-informed care is understanding that past and ongoing exposure to stress and trauma can directly shape health outcomes. But by remaining blind to these histories, the medical community severely limits its ability to address the very drivers of the diseases it is trying to cure.
The post Medicine Understands Trauma’s Impact, But Rarely Asks About It appeared first on
Press Release Service: Vertex Announces US FDA Approval for Expanded Use of CASGEVY® for the Treatment of People Ages 2 Years and Older With Sickle Cell Disease or Transfusion-Dependent Beta Thalassemia CRISPR Medicine News
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.
Rule. The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction 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 non-medicated topical formulation for treatment of erectile dysfunction. We are t
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators 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 active noise attenuation system for infant incubators. We are taking this action because we have det
→ New FDA guidance — may shift practice or documentation expectations.
Drug spending continues to grow, but that doesn’t mean that everyone is getting the medicines that they need. A panel at MedCity News’ Bullseye event discussed the evolution of the prescription drug marketplace.
The post A Prescription for Drug Costs: Inject Transparency and Improve Accessibility appeared first on MedCity News .
Health tech investors say the founders who win them over aren’t the ones with all the answers, but the ones who know exactly what they don’t know — and build a team to cover the gap.
The post What Health Tech Investors Love in Founders — and What They Can’t Stand appeared first on MedCity News .
Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older The AI Journal
Results posted 2026-07-24. Condition: Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. This randomized clinical phase III trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with cancer. Regular physical activity after receiving treatment for cancer may help to maintain a healthy we
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Type 2 Diabetes. The objective of this protocol is to answer the questions: 1) Are financial incentives layered upon nurse education and home telemonitoring superior to nurse education and home telemonitoring alone in improving metabolic control long term? 2) Are the effects of financial incentiv. Sponsor: State University of New York at Buffalo. Status: COMPL
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Quality of Life, Disabilities Multiple. The social distancing requirements for COVID-19 coupled with the adverse health impacts of social isolation and decreased access to healthcare in rural areas places older adults with disabilities in a dire situation. The smart sensor system to be deployed and studied in this proj. Sponsor: University of Missouri-Columbia
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Overactive Bladder Syndrome. This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.. Sponsor: University Hospitals Cleveland Medical Center. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Stroke, Healthy Adult. The purpose of this proposal is to use novel video-based movement tracking technology to measure gait quality after stroke - in the home. Current rehabilitation practice assesses walking in the highly controlled 'ideal' clinical environment. The implicit assumption by clinicians . Sponsor: Western University of Health Sciences. Status: C
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Myocardial Infarction. The purpose of this study is to look at the link between emotional stress and heart disease in men and women. Taking part in this study involves one clinic visit, one week of at home monitoring, and follow up phone calls every 6 months for 3 years.. Sponsor: Emory University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Latent Tuberculosis. Hypotheses: Rifapentine (given as water-dispersible monolayer and/or fixed dose combination with isoniazid) dosing in HIV-infected and uninfected children ≤ 12 years of age with latent TB infection (LTBI) or with exposure to Mycobacterium tuberculosis (M. tuberculosis) will requi. Sponsor: Centers for Disease Control and Prevention. Status
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Migraine. The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study).
Secondary objectives are to. Sponsor: Teva Branded Pharmaceutical Products R&D LLC. Status: COMPLET
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Adult Survivors of Childhood Leukemia. The EQUAL study has been designed for adult survivors of childhood acute lymphoblastic leukemia (ALL) who are overweight or obese. The purpose of this study is to see if diet and exercise can help people lose weight and improve other health problems. This two year study will comp. Sponsor: Memorial Sloan Kettering Cancer
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Cigarette Smoking. The Free Samples for Health (FreSH) study tests whether providing free samples of stop smoking medicine called nicotine replacement therapy at dental visits results in a greater number of people quitting smoking than providing a gift of equal value (an electric toothbrush).. Sponsor: Sandra Japuntich. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Substance Use Disorders, Infection, Soft Tissue, Bacteremia, Osteomyelitis Acute. Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course. We aim to determine the efficacy of an alternative strategy using intermittent outpatient oritavan
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Contraception. This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex (NRL) male condom.
The purpose of this study is to see how well the experimental condoms perform compared . Sponsor: Reckitt Benckiser Healthcare (UK) Limited. Status: COMPL
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Cancer. The purpose of this study is to examine the feasibility of the ambulatory monitoring protocol, called Pain Buddy, in documenting children's pain, symptoms and quality of life while receiving outpatient chemotherapy. The long term goal of Pain Buddy is to help doctors, nurses, and. Sponsor: University of California, Irvine. Status: COMPLETED. Phase: N/A
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Paroxysmal Atrial Fibrillation. Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single shot devices are increasingly used for PVI. Currently, Medtronic Arctic Front cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming techn. Sponsor: Insel Gruppe AG, University Hospital Be
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Trauma, PTSD, Endothelial Dysfunction. This study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (PTSD) increases cardiovascular disease (CVD) risk, and whether posttraumatic fear-a key component of PTSD-or another PTSD dimension could be the t. Sponsor: University of California, Los An
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Psychomotor Impairment. Alcohol and cannabis are the two most widely used substances of abuse in the world and are the psychoactive substances most often found in seriously and fatally injured drivers. In a recent study, it was observed that individuals who reported both driving under the influence of a. Sponsor: Centre for Addiction and Mental Health. Status:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Deep Brain Stimulation. The objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS).
This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning to. Sponsor: Duke University. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Multiple Sclerosis. This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) d. Sponsor: Hoffmann-La Roche. Status: ACTIVE_NOT_RECRUITING. P
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Hypertension. The purpose of this research is to develop ways to reduce hypertension-management-related disparities in the Greater Mankato Area Somali population.. Sponsor: Mayo Clinic. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Atopic Dermatitis. The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.. Sponsor: Amgen. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-24. Condition: Metastatic HER2-Positive Breast Cancer. The purpose of this study is to see if a combination of drugs can help to treat breast cancer. This is a Phase II study which will test whether this combination of drugs is effective and will provide further information on side effects and safety. A standard chemotherapy, gemcita. Sponsor: Memorial Sloan Kettering Cancer
→ New trial — a pipeline signal, not practice-changing yet.
Proposed Rule. The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Evonik Corporation, proposing that we amend our food additive regulations to provide for the safe use of ethyl cellulose as a binder and coating on amino acids incorporated into food for ruminant animals.
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). This meeting was announced in the Federal Register on June 30, 2026. The amendment is being made to reflect a change in the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION: Procedure portion of the document. There are no
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). This meeting was announced in the Federal Register on June 29, 2026. The amendment is being made to reflect a change in the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION: Procedure portion of the document. There are no
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Francis Esteban Matos for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Matos was convicted of a felony under Federal law. The factual basis supporting Mr. Matos's
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement tool 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 intraoperative surgical angle measurement tool. We are taking this action because we have determined that c
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic device 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 diabetes digital behavioral therapeutic device. We are taking this action because we have determined that c
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens 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 over-the-counter test to detect SARS-CoV-2 from clinical specimens. We are taking this
→ New FDA guidance — may shift practice or documentation expectations.
Rule. The Food and Drug Administration (FDA) is classifying the prognostic test for assessment of chronic kidney disease progression 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 prognostic test for assessment of chronic kidney disease progression. We are taking t
→ New FDA guidance — may shift practice or documentation expectations.
The Trump administration released its blueprint for U.S. science, calling for shifting hundreds of billions of research dollars from universities to industry.
Scribe Therapeutics’ IPO will support a pipeline led by a genetic medicine that represses expression of its target gene without making permanent changes. Common chronic cardiometabolic conditions are Scribe’s initial focus as the biotech works to bring genetic medicines beyond rare diseases.
The post CRISPR Biotech Scribe Therapeutics Writes a New Chapter With $129M IPO appeared first on Med
Unlike past healthcare tech waves sold on cost savings, AI is proving it can generate new revenue — with returns as high as 100x, according to a panel of investors at MedCity News’ Bullseye event.
The post Healthcare Investors Are Rewriting the ROI Playbook from Cost-Cutting to Cash Flow appeared first on MedCity News .
July 24, 2026 - Taoyuan City, Taiwan - Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of particulate matter identified as steel. To date, no adverse events or injuries associated with this pa
→ Recall issued — check whether you stock the affected product.
July 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter found in the solution identified as cardboard.
Risk Statement: The use of the defective product has a
→ Recall issued — check whether you stock the affected product.
“Consumers should not be faced with a trade-off between nutrition and food safety,” writes Susan Mayne, former director of the FDA Center for Food Safety and Applied Nutrition.
The decision to no longer seek approval of amlitelimab is the latest setback for a treatment once hailed as a future blockbuster. One analyst expects Sanofi to now pursue “strategic action” to boost its pipeline.
Novo is seeking an injunction that would halt allegedly “misleading” obesity drug ads. Elsewhere, the FDA began reviewing a highly anticipated medicine and a veteran investor landed at an AI startup.
OncologyEndocrine / MetabolicAI in MedicineIndustry & Business
Multiple factors could get in the way of confirming a new commissioner before the midterm elections, experts said, leaving the agency’s long-term initiatives in limbo.
An upcoming Medicare coverage decision for transcatheter aortic valve replacement devices and study readout for patients with moderate disease are expected to help the company maintain its momentum.
CHS’ financial results fell below internal expectations as the hospital operator served more uninsured patients and surgery volumes declined, executives said.
Priority Health partnered with Color Health and Grail to offer self-funded employers virtual cancer navigation, support and multi-cancer early detection beginning in 2027.
The post Priority Health Launches 2 Cancer Support Solutions with Color Health, Grail appeared first on MedCity News .
We’re about to enter a world beyond just talking to a chat tool about your health. AI tools are on the precipice of being able to take action on their advice.
The post AI Will Reshape the Patient Experience appeared first on MedCity News .
The question is no longer whether healthcare innovation is accelerating. The question is where investors gain access to generate the strongest returns.
The post Healthcare’s Next Source of Alpha Is Moving Upstream appeared first on MedCity News .
Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD The Manila Times
Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD Yahoo Finance Singapore
The Trump administration is fighting to restore controversial provisions that a judge threw out last month, including shorter sign-up windows and heightened eligibility verification.
Rule. The Food and Drug Administration (FDA or we) is issuing an order to repeal the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. We have determined that the authorized use of Orange B has been abandoned, and we have concluded that this color additive regulation is outdated and unnecessary. Therefore, FDA is revoki
→ New FDA guidance — may shift practice or documentation expectations.
Proposed Rule. The Food and Drug Administration (FDA or we) is proposing to issue an order that would repeal the color additive regulation that allows for the use of Citrus Red No. 2 for coloring the skins of mature oranges. Based on certification data, it appears that Citrus Red No. 2 is no longer used for coloring the skins of oranges and has not been certified for use as a color additive in foo
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA or Agency) is announcing the publication of FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development (Strategy Document), which outlines actions FDA has taken and the Agency's plans for fiscal years 2026-2027 to facilitate chemistry, manufacturing, and controls (CMC) rea
→ New FDA guidance — may shift practice or documentation expectations.
Notice. The Food and Drug Administration (FDA) is announcing the termination and reestablishment of the Peripheral and Central Nervous System Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Peripheral and Central Nervous System Drugs Advisory Committee was terminated on June 4, 2026, because its charter was not renewed on or before that expiration date. The C
→ New FDA guidance — may shift practice or documentation expectations.
On analyses that looked at major cardiovascular events, those taking retatrutide did not have a significant lower risk of death, heart attack, or stroke.
Mirroring the bipartisan bill introduced in the House, the measure would require a study from the GAO on the state of men’s health in the U.S. to be presented within…
FDA advisers are set to consider whether allowing compounding pharmacies to offer largely unproven peptides is a safer bet than the gray-market versions now in use.
“This change is likely to lead to only modest increases in total medical expenses. However, it coincides with many other factors raising health insurance premiums,” writes Jeff Levin-Scherz.
Assured Health raised $19 million for its AI agents that verify provider credentials and manage insurance enrollment for health systems and group practices. The startup said it can cut a process that usually takes months down to days.
The post Assured Health Secures $19M to Get Providers In-Network Faster with Agentic AI appeared first on MedCity News .
Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of Tuzulby prolonged release 20mg, 30mg and 40…
→ Recall issued — check whether you stock the affected product.
Precision Diabetes and Nagase Diagnostics Announce Exclusive U.S. Commercialization Partnership for Lucica® Glycated Albumin-L, the Only FDA-Cleared Assay Specifically Measured Glycated Albumin in the United States PR Newswire
Results posted 2026-07-23. Condition: Dementia, Hip Pain, Emergency Department Patient, Pain in Advanced Dementia Scale. The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff wi
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Genetic Predisposition. Develop and evaluate acceptability, feasibility, and preliminary efficacy of digital care plan and accompanying text message reminders for children and adolescents with a known Cancer Predisposition Syndromes (CPS).. Sponsor: Children's Hospital of Philadelphia. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Hematopoietic and Lymphoid Cell Neoplasm. This phase II trial studies how well a 2-step approach to stem cell transplant works in treating patients with blood cancers. Giving chemotherapy and total body irradiation before a lymphocyte (white blood cell) and stem cell transplant helps stop the growth of cells in the bone . Sponsor: Sidney Kimmel Comprehensive C
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Refractive Error. This study will be a 12-month, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation conducted at 8 to 14 sites. A total of 383 subjects will be enrolled to achieve approximately 268 treated subjects, resulting in at least 241 evaluable subj. Sponsor: AMO Development, LLC. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Influenza. This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.. Sponsor: Biomedical Advanced Research and Development Authority. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Advanced Cancer, Advanced Solid Tumor, Neoplasm Malignant, Metastatic Cancer. This study is an open-label, multi-arm, parallel cohort, dose validation and expansion design. The study is modular in design, allowing evaluation of the safety, efficacy and pharmacokinetics (PK) of NUC-3373 in combination with other agents for the treatment of patients with dif. Sp
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Arthritis, Psoriatic. The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical r. Sponsor: Janssen Research & Development, LLC. Status: COMP
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Atopic Dermatitis, Moderate-to-severe Atopic Dermatitis. The primary objectives of this study are to:
* estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-tetanus response at Week 24
* estimate vaccine response in rocatinlimab group vs placebo group, assessed using antibody anti-meningococca. Sponsor: Amgen. Status:
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Pulmonary Tuberculosis. This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment.
Participants were randomized to receive either a standard rifampin-based regime. Sponsor: Centers for Disease Control and Prevention. Sta
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Herpes Simplex. A Phase 1 study that will determine the valacyclovir dose that results in a systemic acyclovir exposure comparable to 10 mg/kg of parenterally administered acyclovir, which is an AUC0-12 of 24,000 ngxhr/mL to 48,000 ngxhr/mL. Neonates at risk of acquiring neonatal HSV will be enr. Sponsor: National Institute of Allergy and Infectious Diseases (
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Pancreatic Neoplasms, Cancer of Pancreas, Cancer of the Pancreas, Neoplasms, Pancreatic. This clinical trial adds high-dose ascorbate (vitamin C) to the standard of care regimen for metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). Subjects are randomized between a control group (standard treatment) and an intervention group (pharmacologic as
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Nicotine Withdrawal, Nicotine Addiction, Drug Effect. The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants w. Sponsor: Johns Hopkins Uni
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Alzheimer's Disease. The investigators hypothesize that Nilotinib will be safe in individuals with mild to moderate AD. Specifically, investigators hypothesize that low daily oral doses of Nilotinib will lead to CSF penetration, CNS Abl inhibition, and stabilization of CSF total Tau and p-Tau231/181 . Sponsor: Georgetown University. Status: COMPLETED. Phase: P
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Blood Pressure. This is a prospective observational study to investigate if a non-invasive blood pressure monitoring device, the CareTaker Pulse Decomposition Analysis (PDA), can accurately measure blood pressure in children when compared to an arterial line. Enrolled patients will have the Care. Sponsor: Boston Children's Hospital. Status: COMPLETED. Phase: N
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Hepatitis B, Chronic. This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection. Sponsor: Brii Biosciences Limited. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Intraocular Pressure, Oncology. Steep Trendelenburg positioning and insufflation of the abdominal cavity have shown to increase intra ocular pressure. Different anesthetic techniques can alter intra ocular pressure and a small pilot study showed decrease in Intraocular Pressure (IOP) in robotic case in steep Tr. Sponsor: University of Florida. Status: COMPLETE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Neonatal Anemia. Neonatal anemia is the most commonly encountered hematologic problem among all neonates cared for in the neonatal intensive care unit (NICU). This project seeks to better understand the pathophysiology and treatment of this challenging and important condition, especially as it af. Sponsor: University of Iowa. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Autism Spectrum Disorder, Mental Disorders. This randomized control trial (RCT) seeks to assess the mechanisms underlying Therapeutic Horseback Riding's (THR) previously observed significant positive effects on ASD youth, particularly those with co-occurring psychiatric disorders, and to refine information on the durabilit. Sponsor: University of Colorado, Den
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Pancreatic Cancer, Pancreas Cancer, Pancreatic Adenocarcinoma Resectable, Pancreatic Ductal Adenocarcinoma. The purpose of this study is to see if a treatment regimen with a combination of paclitaxel protein bound (also known as nab-paclitaxel), gemcitabine, and cisplatin when given with high dose Ascorbic Acid will be safe and effective in individuals with un
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Acute-On-Chronic Liver Failure, Ascites. A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute. Sponsor: Genfit. Status: TERMINATED. Ph
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Leukemia, Lymphoma, Childhood Cancer. This study will explore feasibility and acceptability of using a daily mobile mindfulness app to cope with stress. In addition, feasibility of digital health data collection procedures including wrist-worn devices and ecological momentary assessments will be examined.
PRIMARY OB. Sponsor: St. Jude Children's Research Hosp
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Atopic Dermatitis. The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.. Sponsor: Amgen. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Postoperative Insomnia, Postoperative Delirium. The study is a parallel group, double blind, randomized trial. Subjects will be recruited from individuals undergoing elective surgery for orthopedic, abdominal, urologic, gynecologic or spine reasons. Out of 92 subjects, one experimental group of 46 subjects will receive 20 mg S. Sponsor: Columbia University. St
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-23. Condition: Acute Myeloid Leukemia. This study includes patients with relapsed acute leukemia who have previously been treated with standard treatment that is still present and there is no curative treatment option available. Researchers are studying whether the drug Gemtuzumab Ozogamicin, followed by an infusion o. Sponsor: Brown University. Status: COMPLETED. Phase: Pha
→ New trial — a pipeline signal, not practice-changing yet.
The European Medicines Agency is taking what advocacy groups are calling unexpectedly “rapid action” to ensure that clinical trial results are made public as required by law.
Has a wanted fugitive been posing as a biotech executive? And what does it take to develop a therapy for an ultra-rare disease? Find out on this week's episode of…
Endocrine / MetabolicDigital healthIndustry & Business
A study of Lilly's retatrutide weight loss drug in people with heart disease did not answer a crucial question — whether it reduces cardiovascular risk
The startup is the first gene editing company to price an IPO in more than two years, though it banked far less than most other biotechs that have gone public in 2026.
In a victory for Robert F. Kennedy Jr.’s “MAHA” agenda, panelists narrowly recommended broader use of six of the seven peptides up for consideration despite a lack of substantive evidence supporting their benefits and safety.
The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
Molina’s second quarter was complicated, with stability in Medicaid and outperformance in Medicare Advantage overshadowed by problems in the ACA exchanges. The trend was “unfortunate,” according to the insurer’s CEO.
Brian Manning, who previously worked at health tech companies like Bamboo Health and Zocdoc, has replaced the AI company’s co-founder and former CEO Alex LeBrun.
SCAN Health Plan CEO Sachin Jain and Ascendiun CEO Paul Markovich argued that healthcare leaders share responsibility for the industry’s shortcomings and called for greater accountability and systemic reform.
The post Who Broke the Healthcare System? appeared first on MedCity News .
Hospitals that see improved long-term results in behavioral health patients will be those that prioritize metrics aligned with their care pathways.
The post Rethinking How Hospitals Measure Behavioral Health Success appeared first on MedCity News .
Groundbreaking new therapies have exciting potential to treat and cure diseases while minimizing burden on patients; however, they create major clinical, operational and financial implications that must be planned for years in advance.
The post Four Ways Health Systems Should Plan for the Next Wave of Breakthrough Therapies appeared first on MedCity News .
Providers and payers initiated 16% more disputes in the second half of 2025 compared with the first half, according to new federal data. But arbiters are closing challenges more quickly and tackling a backlog of disputes.
Results posted 2026-07-22. Condition: End Stage Liver DIsease, Liver Failure. This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using s. Sponsor: Bridge to Life Ltd.. Status: CO
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Fall, Alzheimer Disease. This longitudinal cohort study investigates cognitively normal participants with and without preclinical Alzheimer disease (AD) in order to examine: (1) the relationship between falls and functional mobility in preclinical stages of AD; and (2) a hypothesized model of central and. Sponsor: Washington University School of Medicine. Stat
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Obesity Prevention. The goal of this clinical trial is to test a new web-based promotora de salud/ community health worker (CHW) training. This training is designed to provide CHWs with the knowledge and skills to effectively implement a healthy living intervention for Latinas. The main question it . Sponsor: ISA Associates, Inc.. Status: COMPLETED. Phase: N/A
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Colorectal Cancer (CRC). The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipir. Sponsor: Amgen. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Mental Disorders. A growing number of trials have demonstrated treatment effectiveness for people with mental illness (PWMI) by non-specialist providers, such as primary care and community health workers, in low-resource settings. A barrier to scaling up these evidence-based practices is the limit. Sponsor: Brandon A Kohrt, MD, PhD. Status: COMPLETED. Phase: N
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Psychological Stress. Older adults have been disproportionately impacted and distressed by the novel coronavirus (COVID-19) pandemic. Social distancing and stay-at-home orders have increased older adults' risk of social isolation and loneliness that will has led to a pandemic-induced fear of being in . Sponsor: VA Office of Research and Development. Status: CO
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: EBV, Epstein-Barr Virus Infection, Infectious Mononucleosis. Background:
Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Up to 1 in 10 people who get mono can have fatigue that lasts more than 6 months. One out of 100 people can have severe complications. EBV is also associated with several types of cancer. . Sponsor: National I
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Microsatellite Stable Metastatic Colorectal Cancer. This Phase 2 clinical study will evaluate evorpacept (ALX148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer. Sponsor: University of Colorado, Denver. Status: TERMINATED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Asthma in Children. The main purpose of this study is to look at whether clinicians and their patients with asthma can satisfactorily perform remote asthma management at home (not visiting clinic) by using an artificial intelligence tool called Asthma-Guidance and Prediction System combined with a h. Sponsor: Mayo Clinic. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Dyadic Family Caregiver-person With Dementia Online Intervention. The purpose of this study is to evaluate an online platform -- the Living Memory Home for Dementia Care Pairs (LMH-4-DCP) for persons with dementia and their family caregivers to engage in reminiscence activities together and record meaningful memories.
The main aims of this stu. Sponsor: Weill
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Post Operative Surgical Site Infection. The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the . Sponsor: Major Extremity Trauma Research
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Hypertension. The investigators hypothesize that communities in which religious leaders are provided with education about blood pressure and how to measure blood pressure will have lower overall average blood pressures than communities in which religious leaders do not receive education about . Sponsor: Weill Medical College of Cornell University. Status: SUSP
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Healthy. This clinical investigation is a single centre, double blinded, case control study in healthy adult females. This study will be conducted in private rooms at Gentofte Hospital (Hjerte-medicinsk Forskning, post 835, Kildegårdsvej 28, 2900 Hellerup).
The investigation centre will . Sponsor: Ambu A/S. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Stress Urinary Incontinence. The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.. Sponsor: Corewell Health East. Status: TERMINATED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Mantle Cell Lymphoma. This phase II trial investigates how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma. Sponsor: Academic and Community Cancer Research United. St
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Obesity. The phenomenon of physical activity (PA) avoidance in obesity has been detailed in the literature, but there is a lack of programs designed to address the root causes. In addition to common PA barriers such as lack of time, individuals with obesity face weight-related impediments. Sponsor: Emory University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal, Gastroesophageal Reflux, Acid Reflux. The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-co
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Coronary Artery Disease. To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.. Sponsor: Boston Scientific Corporation. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Chronic Patellar Tendinopathy, Chronic PT. The goal of this study is to find an effective treatment for chronic patellar tendinopathy (PT). Investigators will conduct a 32-week randomized controlled clinical trial to determine whether platelet rich plasma (PRP) injections improve disease-specific clinical outcomes with co. Sponsor: University of Wisconsin, Mad
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: PTSD, Trauma. This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control. Enrollment will be targeted to create three groups within . Sponsor: Emory University. Status: COMPLETED. Phase: Early Phase 1
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-22. Condition: Chronic Pain, Exposure, Adolescent Behavior, Child Behavior. This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental de. Sponsor: Stanford U
→ New trial — a pipeline signal, not practice-changing yet.
Notice. The Food and Drug Administration (FDA, Agency, or we) has determined that RASUVO (methotrexate) solution, 27.5 milligrams (mg)/ 0.55 milliliter (mL) (27.5 mg/0.55 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 RASUVO (methotrexate) solution, 27.5 mg/0.55 mL (27.5 mg/0.55 mL)
→ 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.
At least 78 AHRQ grants worth $200 million have been affected by "non-award" notices; it's estimated those grants had $109.2 million in funding remaining.
Senior leaders must treat AI governance as their own daily job, not something the technology committee handles quarterly, write Peter Pronovost, Justin Norden, and Kedar Mate.
The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in the U.S. or Europe.
The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again.
New data supports the idea that Merck’s Ebola vaccine Ervebo, licensed to target the Zaire species of ebolaviruses, could also offer some protection against another.
“Hospitals often make Argentina’s mistake: We confuse continuity with progress,” writes physician, hospital administrator, and bioethicist Basel Tarab.
President Trump plans to impose tariffs on imported generic medicines, his latest threat aimed at bringing pharmaceutical manufacturing back to the U.S.
Analysts expect new details on the lead-up to the deal “are likely to reignite” investor scrutiny that Vertex overpaid in what’s poised to be its largest-ever transaction.
To analysts, the drug’s apparent safety and effects on both triglyceride levels and pancreatitis cases should make it competitive with a rival Ionis therapy.
While the possibility of levies on branded pharmaceuticals have had a limited impact on drugmaker revenues, tariffs of up to 200% on copycat medicines could — depending on the specifics — prove more disruptive.
A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competitor emerged.
Andrew Aberdale will help expand AiM’s strategic partnership ecosystem, including its recent collaboration with Siemens Healthineers, the company said.
While Johnson & Johnson will go head to head with Intuitive in the U.S., analysts questioned whether its robotic surgery system will take meaningful share from the market leader.
The rule pitched Wednesday would make it easier for group health plans regulated by ERISA to share mandatory notices with their members. A DOL official called the proposal a “big step forward.”
More Americans are keeping jobs they would otherwise leave for fear of losing their insurance, as healthcare costs rise and non-employer coverage seems less affordable, according to a new poll.
AdventHealth is expected to have a majority interest in the partnership, which will unite Denver-area hospitals and clinics owned by the two nonprofits. The deal is expected to close early next year.
The new proposed rule is meant to prevent states from guaranteeing providers will be refunded for their taxes, and should save Washington $246 billion over the next decade, regulators said.
GSK drug Jideytro received FDA approval for treating advanced cases of non-small cell lung cancer driven by ROS1 alterations. This molecule came from Nuvalent, which GSK recently acquired for $10.6 billion.
The post $10B M&A Deal Pays Off With GSK’s First Lung Cancer Drug Approval appeared first on MedCity News .
Headspace announced partnerships with Charlie Health, Cortica, Prosper Health and Equip.
The post Headspace Teams Up with 4 Companies for Specialty Care appeared first on MedCity News .
Women have to navigate the fragmented system with very little support, coordinating between providers and often interpreting conflicting guidance.
The post Hidden in Plain Sight: The Cost Crisis in Women’s Healthcare appeared first on MedCity News .
At the end of the day, the most important question is a simple one: Do you actually know if you’re being reimbursed correctly?
The post What Healthcare Organizations Miss When It Comes to Reimbursement Accuracy appeared first on MedCity News .
The policy conversation needs to shift from just deprescribing alone to building the clinical infrastructure that delivers consistent, high-quality behavioral health care.
The post Better Prescribing, Not Less Prescribing, Is What Behavioral Health Needs appeared first on MedCity News .
DARPA Selects NRx Pharmaceuticals Defense Subsidiary for Contract Negotiations on FDA-Authorized SPARC-TMS Clinical Trial Advancing Mental Health Care PRLog
Shareholders approved a plan to dissolve the robot developer, at one time a well-financed contender to challenge surgical robotics leader Intuitive, and liquidate its assets.
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.. Class II Reason: Lack of Assurance of Sterility
→ Class II recall — verify affected lots; temporary or reversible risk.
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.. Class II Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
→ Class II recall — verify affected lots; temporary or reversible risk.
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.. Class II Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
→ Class II recall — verify affected lots; temporary or reversible risk.
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31. Class II Reason: Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
→ Class II recall — verify affected lots; temporary or reversible risk.
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35. Class II Reason: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
→ Class II recall — verify affected lots; temporary or reversible risk.
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.. Class II Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
→ Class II recall — verify affected lots; temporary or reversible risk.
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,. Class II Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
→ Class II recall — verify affected lots; temporary or reversible risk.
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.. Class II Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
→ Class II recall — verify affected lots; temporary or reversible risk.
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.. Class II Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
→ Class II recall — verify affected lots; temporary or reversible risk.
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.. Class II Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
→ Class II recall — verify affected lots; temporary or reversible risk.
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device. Class II Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
→ Class II recall — verify affected lots; temporary or reversible risk.
Rapid Refill Continuous Injection System, UPN M00566001. Class II Reason: Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or se
→ Class II recall — verify affected lots; temporary or reversible risk.
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories. Class I Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23
→ Class I recall — stop use, check your stock, switch to alternatives.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories. Class I Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable b
→ Class I recall — stop use, check your stock, switch to alternatives.
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump. Class II Reason: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
→ Class II recall — verify affected lots; temporary or reversible risk.
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders. Class II Reason: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
→ Class II recall — verify affected lots; temporary or reversible risk.
Optima XR200amx, Mobile Digital-Ready Radiographic System. Class II Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causin
→ Class II recall — verify affected lots; temporary or reversible risk.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories. Class I Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detec
→ Class I recall — stop use, check your stock, switch to alternatives.
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.. Class II Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
→ Class II recall — verify affected lots; temporary or reversible risk.
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.. Class I Reason: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
→ Class I recall — stop use, check your stock, switch to alternatives.
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders. Class II Reason: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
→ Class II recall — verify affected lots; temporary or reversible risk.
Optima XR220amx, Mobile Digital-Ready Radiographic System. Class II Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causin
→ Class II recall — verify affected lots; temporary or reversible risk.
General Biospy Tray, REF: GUTS1000. Class I Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
→ Class I recall — stop use, check your stock, switch to alternatives.
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204. Class II Reason: The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total
→ Class II recall — verify affected lots; temporary or reversible risk.
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.. Class II Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
→ Class II recall — verify affected lots; temporary or reversible risk.
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.. Class II Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
→ Class II recall — verify affected lots; temporary or reversible risk.
Arterial Line Kit 20ga x 6, REF: 400115A. Class I Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
→ Class I recall — stop use, check your stock, switch to alternatives.
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories. Class I Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are prov
→ Class I recall — stop use, check your stock, switch to alternatives.
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A. Class I Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
→ Class I recall — stop use, check your stock, switch to alternatives.
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump. Class II Reason: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
→ Class II recall — verify affected lots; temporary or reversible risk.
One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular. Class I Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
→ Class I recall — stop use, check your stock, switch to alternatives.
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device. Class II Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
→ Class II recall — verify affected lots; temporary or reversible risk.
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267. Class II Reason: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
→ Class II recall — verify affected lots; temporary or reversible risk.
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories. Class I Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every p
→ Class I recall — stop use, check your stock, switch to alternatives.
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device. Class II Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
→ Class II recall — verify affected lots; temporary or reversible risk.
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories. Class I Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable b
→ Class I recall — stop use, check your stock, switch to alternatives.
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula. Class II Reason: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
→ Class II recall — verify affected lots; temporary or reversible risk.
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL. Class I Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
→ Class I recall — stop use, check your stock, switch to alternatives.
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories. Class I Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Intr
→ Class I recall — stop use, check your stock, switch to alternatives.
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.. Class II Reason: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28
→ Class II recall — verify affected lots; temporary or reversible risk.
Optima XR240amx, Mobile Digital Radiographic System. Class II Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the
→ Class II recall — verify affected lots; temporary or reversible risk.
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device. Class II Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
→ Class II recall — verify affected lots; temporary or reversible risk.
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.. Class II Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
→ Class II recall — verify affected lots; temporary or reversible risk.
Notice. The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of June 24, 2026, to open a public docket to solicit input and comments on a proposal to establish a pilot program, the Expedited Investigational New Drug (IND) pilot program, to shorten the time it takes from drug identification to first-in-human (FIH)
→ New FDA guidance — may shift practice or documentation expectations.
Novo Nordisk sued Eli Lilly for allegedly running a “deceptive” ad campaign that uses “outdated clinical trials” to make its obesity and diabetes drugs appear more effective.
“Post-pandemic polarization threatens to lock our memories into attractive, untrue conclusions that will leave us unprotected next time,” write Marc Lipsitch and Sara Cody.
THC drinks, which have exploded in popularity in recent years, are sold in retail stores beside sodas, iced tea, and even chocolate milk, often in violation of state laws.
[Sponsored] A five minute survey from MedCity News asks payers what they think of AI and how it is being implemented. Participate today and we will reward you!
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Results posted 2026-07-21. Condition: Critical Illness. This study will use point of care (POC) gastric ultrasound to confirm that nasojejunal tube (NJ) feeds result in minimal to no gastric content and therefore are low risk for aspiration and should be allowed at the very least to decrease the time that enteral feeds need to be held. Sponsor: Joseph D. Tobias. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Recurrent Basal Cell Carcinoma. This is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participant. Sponsor: Sol-Gel Technologies, Ltd.. Status: TER
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Critically Ill Patients. Intubation in the intensive care unit (ICU) is usually an emergency. Pathophysiological changes such as shock, respiratory failure, and metabolic acidosis in critically ill patients can significantly increase the incidence of adverse events during intubation.
Studies have shown . Sponsor: Union Hospital, Tongji Medical College, Huazho
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Untreated Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma. To evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.. Sponsor: HonorHealth Research Institute. Status: COMPLETED. Phase: Ph
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Breast Cancer. This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.. Sponsor: Context Therapeutics Inc.. Status: TERMINATED. Phase: Phase 1, Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: HER2 Negative Metastatic Breast Cancer. 90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression free survival between the 2 groups. If results at tha. Sponsor: University Hospitals Bristol an
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Visual Analog Pain Scale. Capillary blood glucose measurement is a routine procedure in emergency departments, but it may cause pain and discomfort because it requires fingertip puncture. Vapocoolant spray is a rapid, noninvasive, and inexpensive method of topical analgesia that may reduce pain during min. Sponsor: Abant Izzet Baysal University. Status: COMPLE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Invasive Mechanical Ventilation, Children With Medical Complexity, Home Nursing, Empowerment. The objective of the study is to pilot a parent-to-parent coaching model with experienced family members of children with Invasive Mechanical Ventilation (IMV) as parent coaches.. Sponsor: University of Chicago. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Covid19, Vaccine Refusal, Vaccine Hesitancy. This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasin. Sponsor: Xavier University of Louis
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Heart Failure. The goal of this study is to compare measured respiration rates in various subject scenarios and use conditions between capnography and the Crome and Cobalt ICD and CRT-D MRI SureScan devices (derived using a Holter recorder).. Sponsor: Medtronic Cardiac Rhythm and Heart Failure. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Phenylketonuria (PKU). This is a Phase 3 open-label randomized controlled study enrolling approximately 54 adolescents with PKU. The study is designed to assess the safety and efficacy of pegvaliase injections.. Sponsor: BioMarin Pharmaceutical. Status: ACTIVE_NOT_RECRUITING. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Non Malignant Diseases, Immunodeficiencies, Hemoglobinopathies. This Phase II pilot study evaluates the safety and effectiveness of reduced-intensity conditioning (RIC) regimens prior to allogeneic hematopoietic stem cell transplantation (HSCT) in pediatric and young adult patients with non-malignant disorders, including immunodeficiencies an. Sponsor: Childre
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Pediatric Asthma. Underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. Current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical . Sponsor: Indiana University. Status: TERMINATED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: NASH - Nonalcoholic Steatohepatitis. This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.. Sponsor: Akero Therapeutics, Inc. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Atopic Dermatitis, Skin Diseases, Eczema. Atopic dermatitis (eczema) is a complicated skin condition. In fact, it represents many different underlying problems. These include abnormalities in the skin barrier, the immune system and the ability to handle different bacteria. Despite many recent gains in the understanding o. Sponsor: Women's College Hospital. Sta
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Plaque Psoriasis. This is a Phase 2, multicenter, randomized, double-blinded, parallel dose group, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of 2 doses of TLL018 as therapy in approximately 90 participants with moderate-to-severe PP.. Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Dental Caries. The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.. Sponsor: Colgate Palmolive. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-21. Condition: Locally Advanced Angiosarcoma, Metastatic Angiosarcoma, Recurrent Angiosarcoma. This phase II trial evaluates the effect of sintilimab in treating patients with angiosarcoma that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or has come back (recurrent). Immunotherapy with monoclonal antib.
→ New trial — a pipeline signal, not practice-changing yet.
The Trump administration said it was deferring more than $1 billion in Medicaid payments to Minnesota and California because of “suspected fraud and noncompliance.”
The study failure costs Agios a chance to one-up Novo Nordisk and represents yet another setback in a disease that’s frustrated drugmakers of late.
The lawsuit follows a cease-and-desist request and argues Lilly is using “deceptive” ads to claim its GLP-1 products are broadly superior to Novo’s medicines. Lilly countered that its campaign is “truthful.”
The young venture firm, which has bet heavily on tech and biotech’s convergence, has now invested in 35 companies and recently saw one of them acquired by AI giant Anthropic.
A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.
Philips said its updated device provides accurate readings across a range of skin tones, following concerns that pulse oximeters can be less accurate in people with darker skin pigmentation.
The computing platform will make its debut at the Society of Robotic Surgery meeting this week, as Medtronic challenges Intuitive in the U.S. robotic soft tissue market.
The HHS halted more Medicaid funding to the states on Tuesday, citing concerns about fraud. Critics have slammed the “attack first, ask questions later” strategy of the deferrals, which have only impacted blue states to date.
Prediction market Kalshi launched betting markets tied to clinical trial results and FDA approvals. Healthcare leaders warn the model could invite insider trading and distort the integrity of the research outcomes it’s meant to forecast.
The post You Can Now Bet on Clinical Trials Like Playoff Games, But Health Execs Say It Crosses a Line appeared first on MedCity News .
Rep. Angie Craig introduced a bill to establish a public health insurance option on the ACA marketplaces and permanently extend enhanced premium tax credits.
The post New Bill Seeks to Create Public Option on ACA Marketplaces appeared first on MedCity News .
Agios Pharmaceuticals said tebapivat fell short of expectations in a Phase 2 test in sickle cell disease. It’s the latest in a series of disappointing industry developments in sickle cell disease.
The post Agios Pharma Drops Sickle Cell Disease Drug After Phase 2 Data Disappoint appeared first on MedCity News .
Screening for mental health symptoms in patients with significant allergic disease is not overreach
The post How Diagnostic Precision in Allergy Care Supports Mental Well-Being appeared first on MedCity News .
Healthcare decision-makers, especially at pharmaceutical companies, must prioritize patient input. Data collected from social media listening is a significant step in the right direction.
The post Why Pharma Companies Should Look To Social Media For Better Patient Insight appeared first on MedCity News .
Results posted 2026-07-20. Condition: Health Knowledge, Attitudes, Practice, Vaccine-Preventable Diseases, Intention, Adherence, Patient. Community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region will be recruited to compare psychoeducational multimedia interventions focused on the human papillomavirus (HPV). Our hypothesis is that adults who view culturally tailo
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Cognitive Dysfunction, Dementia, Mild. This study will investigate the efficacy of a newly developed exercise device (FitMi AD) for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. FitMi AD uses embedded sensors that can track and record the patient's direction and degree o. Sponsor: Flint Rehabilitation Devices, LL
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: IgA Nephropathy, Immunoglobulin A Nephropathy. The ASSIST study was a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).. Sponsor: Novartis Pharmaceuticals. Status: COMPLETED.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Femoral Neck Fractures. This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up. The patients are d. Sponsor: Peking University Third Hospital. Status: COMPL
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Hypertension. The purpose of the ARTERY Outcomes study is to compare optima-for-blood pressure (optima4BP), a clinical decision support system for hypertension (HTN) treatment optimization to standard of care in patients with essential HTN.. Sponsor: Optima Integrated Health. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Stage IB Hepatocellular Carcinoma AJCC v8, Stage II Hepatocellular Carcinoma AJCC v8, Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8. This phase II trial tests whether regorafenib and durvalumab work to shrink tumors in patients with high-risk liver cancer. Regorafenib may stop the growth of tumor cells by blocking some
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Hypertension, Pulmonary. The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.. Sponsor: Actelion. Status: ACTIVE_NOT_RECRUITING. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Rheumatoid Arthritis. The primary objective is to determine if the addition of a 12-week course of treatment with VIB4920 to TNFi treatment will result in improved clinical disease control in patients with RA who have had an inadequate response to a TNFi.. Sponsor: National Institute of Allergy and Infectious Diseases (NIAID). Status: TERMINATED. Phase: Phase
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Nephrectomy, Prostatectomy. The purpose of this clinical investigation was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments and accessories in patients with the indication of . Sponsor: Rob Surgical Systems S.L.. Status: COMPLETE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Gastroparesis With Diabetes Mellitus. The device being studied, the Transcutaneous Electrical Accustimulator (TEA), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. The study team would like to te. Sponsor: University of Michigan. Status: C
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Diabetic Foot Ulcer. This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU). Sponsor: Rion Inc.. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Relapsed Chronic Lymphocytic Leukemia. Metformin is an antidiabetic drug which is an inexpensive and generally well tolerated medication. More recently metformin has been shown to act against carcinomas by two mechanisms: 1) an indirect, insulin-dependent mechanism which sensitizes tissues to insulin, inhibits hepatic. Sponsor: University of Michigan Rogel Can
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Burn. A dietary antioxidant, alpha-tocopherol, will be used to potentially attenuate Vitamin E short- and long-term losses in plasma and adipose, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including lung injury a. Sponsor: The University of Texas Medical Branch, Galveston. Status: COMPLE
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Healthy Brain Perfusion. This study uses magnetic resonance imaging to determine whether 3 weeks of repeated exposure to Acute Intermittent Hypoxia can improve brain blood flow or blood flow regulation in healthy adults.. Sponsor: Northwestern University. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: HIV-associated Tuberculosis. A5406 hypothesized that dolutegravir (DTG) 50 mg taken twice daily provides adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated tuberculosis (TB).. Sponsor: National Institute of Allergy and Infectious Diseases (NIAID). Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Multiple Sclerosis, Relapsing-Remitting. Multiple sclerosis (MS) is an inflammatory autoimmune disease associated with an imbalance between pro- and anti-inflammatory markers (cytokines) resulting in a demyelinating and neurodegenerative disease. There is early evidence that spinal manipulation (chiropractic care) is be. Sponsor: University of Alabama at Birmi
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Obesity. The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.. Sponsor: Eli Lilly and Company. Status: COMPLETED. Phase: Phase 3.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Substance Use Disorder (SUD). This is a post-market clinical follow-up study on an approved CE-marked eHealth system where a mobile phone application is used to measure the pupils and eye measurements to monitor the use of different drug substances. The goal of the study is to collect additional information w. Sponsor: Kontigo Care AB. Status: COMPLETED. Phase
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Glioblastoma, Glioblastoma Multiforme. This clinical trial evaluates adding ferumoxytol and pharamcologic ascorbate (vitamin C) to standard of care treatment of glioblastoma multiforme (a type of brain tumor) in adults. All subjects will receive ferumoxytol and pharmacologic ascorbate in addition to the standard treat. Sponsor: Bryan Allen. Status: ACTIVE_NOT_
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Metastatic Esophageal Squamous Cell Carcinoma. The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.
The primary hypotheses are that pembro. Sponsor: Merck Sharp & Dohme LLC.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Prostate Adenocarcinoma. This is a double-blinded, placebo-controlled randomized phase II clinical trial investigating whether flibanserin promotes sexual interest in men with prostate cancer who are receiving androgen suppression.. Sponsor: Andrew McDonald. Status: COMPLETED. Phase: Phase 2.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Alzheimer Disease, Dementia. This study is an RCT to evaluate the effectiveness of Brain Safe on reducing anticholinergic exposure. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Bra. Sponsor: Indiana University. Status: COMPLETED. Pha
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Chemotherapy-induced Peripheral Neuropathy. This study will perform an early Phase I feasibility study with single-arm, double-baseline repeated measured design. The investigators will test the feasibility of using focal vibration to improve symptoms of persistent CIPN.. Sponsor: University of Oklahoma. Status: COMPLETED. Phase: N/A.
→ New trial — a pipeline signal, not practice-changing yet.
Results posted 2026-07-20. Condition: Health Personnel Attitude, Health Knowledge, Attitudes, Practice. Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies abou. Sponsor: Unive
→ New trial — a pipeline signal, not practice-changing yet.
An audit of state Medicaid records revealed how PBMs are using complicated tactics for handling prescription drug claims that ultimately overcharge taxpayers.
LifeMD, a popular telehealth company, has been accused by former employees of pressing clinicians to mete out prescriptions more rapidly without sufficient screening and follow-up.
A new PwC report says the women’s oncology market could reach $110 billion by 2030, though funding and care gaps remain.
The post Women’s Oncology Market Could Reach $110B in 2030, but Gaps Remain appeared first on MedCity News .
Aspectos destacados de la declaración:
La investigación más reciente indica que consumir hasta 400 mg de cafeína por día (el equivalente a 5 tazas de 230 ml de café al día) en general es seguro para la mayoría de los adultos y, al parecer, en algunas...
→ New FDA guidance — may shift practice or documentation expectations.
Statement Highlights: The latest research indicates that consuming up to 400 mg of caffeine/day (equivalent to up to 5, 8-ounce cups of caffeinated coffee per day) is generally safe for most adults and appears to be linked to a lower risk of several ...
→ New FDA guidance — may shift practice or documentation expectations.
Baxter administration sets may have air bubbles in the drip chamber and tubing, which may result in air being delivered through the IV line to the patient.
→ Recall issued — check whether you stock the affected product.
FOR IMMEDIATE RELEASE – July 18th, 2026 – Panoli, Gujarat, Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross contamination with Ranitidine.
→ Recall issued — check whether you stock the affected product.
The FDA said Monday it is still focused on lettuce from Taylor Farms as the source of a multistate outbreak of a diarrhea-causing parasite, despite a faulty test result.
The Westlake-founded company specializes in non-opioid drugs that target sodium ion channels, and is now adding to what’s already been a busy month for the biotech IPO queue.
Bristol Myers is the third pharmaceutical company to recently seek Nvidia’s help building a large AI data center. Elsewhere, a Novartis kidney drug gained a leg up on competitors.
The supply of the circuit boards needed to fix the devices is significantly constrained, preventing the company from immediately correcting all affected ventilators.
The bankruptcies come as the healthcare sector faces looming financial pressures, including cuts to Medicaid, according to the report by Gibbins Advisors.
The insurer, which disclosed the breach in a securities filing late last week, doesn’t yet know what type of data was exposed or how many people may have been impacted.
As hospitals increasingly use AI to improve patient care, the same technology is being used by hackers and nation-states to launch faster, more sophisticated attacks. Karen Habercoss, chief information security and privacy officer at the University of Chicago Medicine, explained how her health system is building a governance structure to manage that risk.
The post The Same AI That Helps Patient
A new report from the Peterson Health Technology Institute argues that today’s healthcare payment models are ill-suited for clinical AI and could drive up costs.
The post How Should Clinical AI Be Paid For? 3 Takeaways appeared first on MedCity News .
Personalis’s liquid biopsy is part of a growing market for minimal residual disease assays, tests that look for any remaining cancer cells after the initial treatment. Tempus AI has been the commercial partner on this Personalis test since 2023.
The post Expecting Massive Test Growth in Cancer & More, Tempus AI Strikes $1.5B Deal to Buy Personalis appeared first on MedCity News .
These three legal regimes are pulling in different directions, and the developers that navigate them well will be the ones that plan for all three from the start.
The post The AI Tension in Healthcare: Patent Strategy, FDA Reality, and HIPAA Constraints appeared first on MedCity News .
Rural Health Transformation Program funding gives states broad flexibility and may help address longstanding access gaps.
The post For Millions in Rural America, Medicine Is Still Far Away appeared first on MedCity News .
Macarthys Laboratories Ltd T/A Martindale Pharma has notified the MHRA of a manufacturing issue impacting several batches of Xaggitin XL Prolonged-release Tablets, due to the occurrence of incorrect tablet counts in the bott…
→ Recall issued — check whether you stock the affected product.
July 20, 2026: North Carolina woman shares experience with hospitalization after telehealth prescribed weight loss drugs Partnership for Safe Medicines
Merck’s Lipfendra is the first FDA-approved pill in the class of cholesterol-lowering drugs called PCSK9 inhibitors. While peptides are typically injected, Lipfendra is a macrocyclic peptide designed for formulation as an oral drug.
The post Merck Pill Becomes First Oral Option in Growing Class of Cholesterol-Lowering Drugs appeared first on MedCity News .
What should life sciences investors and targets focus on for dealmaking success? Here are six actionable steps.
The post Hybrid Financing in Life Sciences: Unlocking Growth Amid Market Challenges appeared first on MedCity News .
Here’s what healthcare entities should know about the maturing landscape, what to actually be concerned about, and the next stage of healthcare data evolution as we know it.
The post Are We Entering an Interoperability Trust Recession? appeared first on MedCity News .
Nothing matches that filter.
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.
Healthtech briefingUpdated today · what's moving in digital health and devices
Bottom line. None of today's items fall within the healthtech desk scope; all are biopharma, opinion, or sponsored content pieces without digital-health, medtech, remote monitoring, telehealth, or clinical AI product news.
No Qualifying Healthtech Items Today
All eight items are biopharma deals, opinions, medical education policy, or sponsored marketing content.So what: Nothing today meets the healthtech brief threshold; no shipping products, device launches, or clinical AI updates to act on.
One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.
Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.
The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.
Claris Bio has appointed veteran CEO Stephen Brady to lead advanced development of what it hopes to be the first drug therapy for a blinding condition called limbal stem cell deficiency.
Dyne Therapeutics Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for DYNE-302 in Facioscapulohumeral Muscular Dystrophy (FSHD) The Manila Times
“Emergency departments across America report dramatic increases in serious injuries from e-bikes and e-scooters,” write CHOP’s J. Todd R. Lawrence and Madison A. Kesler.
Even as some medical schools heed health secretary Robert F. Kennedy Jr.’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t…
[Sponsored] On a recent webinar sponsored by Verato, panelists from SCAN Health Group and the Alliance of Community Health Plans discussed how their organizations are meeting the moment.
The post AI Readiness Starts with Solving Healthcare’s Data Fragmentation Problem appeared first on MedCity News .
As patients increasingly bring AI chatbot advice into exam rooms, where does liability land when that advice goes wrong? Health law attorney Meghan O’Connor said the answer still isn’t clear, but silence is the riskiest response for providers.
The post What Happens When Patients Trust AI Over Their Doctor? appeared first on MedCity News .
The world risks a resurgence of the HIV epidemic after international financing to combat the disease suffered a “profound shock” last year, according to a new report from UNAIDS.
Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
Shares fell more than 66% Monday morning, which analysts suspect is due to investors seeing the data as not competitive with Bristol Myers' Cobenfy.
Capricor shares lost much of their value ahead of a high-stakes advisory committee meeting. Elsewhere, Ying Huang’s resignation extended a stock slide for Legend and AstraZeneca disclosed more pipeline trouble.
Most recently the leader of buzzy startup Tessera Therapeutics, Severino will look to improve the fortunes of a company facing emerging competition and declining sales for its prized gene therapy Elevidys.
Abbott will market Freenome’s SimpleScreen CRC test in the U.S., alongside its Cologuard stool test. SimpleScreen will compete with Guardant Health’s Shield blood test for colorectal cancer screening.
Aidoc is bringing a system that can interpret images and make draft reports for radiologists to the FDA as the medtech industry awaits clarity on regulation of generative AI. Ensuring safety is paramount, said CEO Elad Walach.
The regional nonprofit and surgical facility operator have co-owned the facilities since 2023. But Surgery Partners, which expects to net almost $800 million from the deal, is looking to reorient its portfolio to a more outpatient-heavy model.
Devices / SurgeryIndustry & Business
Companies briefingUpdated today · filings and deals that touch the bedside
Bottom line. Edwards Lifesciences and Novocure results carry the most direct bedside signal this cycle, touching TAVR procedure volumes and TTFields device availability. Diagnostics and lab-supply names reported stable operations with no access disruptions flagged.
Devices in Active Clinical Use
Edwards Lifesciences Q2 results; TAVR and TMTT revenue trends reflect structural heart procedure demand.So what: Stable Edwards financials support continued SAPIEN and PASCAL device supply without near-term access risk.
Novocure Q2 results covering Optune TTFields systems for GBM and ongoing label-expansion studies.So what: Revenue trajectory signals device availability and reimbursement stability for GBM patients currently on TTFields therapy.
Becton Dickinson leadership change filing; no product discontinuation or safety action disclosed.So what: Monitor for strategy shifts affecting BD's broad infusion, injection, and diagnostics portfolio in coming quarters.
Diagnostics and Lab Supply Continuity
Quest Diagnostics Q2 results; no test discontinuation or reimbursement disruption reported.So what: Routine and specialty lab test availability remains intact; no ordering changes needed.
Thermo Fisher Q2 results covering research reagents, instruments, and pharma services segments.So what: No supply constraint signals for clinical-grade reagents or instruments used in hospital and reference labs.
Danaher Q2 results across diagnostics and life-science tools platforms.So what: Cepheid and Radiometer lines appear operationally stable; point-of-care testing supply not flagged at risk.
Health System Operations
HCA Healthcare Q2 results with Reg FD disclosure; same-facility admissions and surgical volumes reported.So what: HCA volume trends serve as a proxy for elective procedure recovery and inpatient capacity at affiliated facilities.
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.
Tracked companies
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.
Trials briefingUpdated today · phase and practice-impact read
Bottom line. Seven completed trials posted results covering pediatric oncology exercise, diabetes incentives, bladder neuromodulation, post-stroke gait tracking, stress-related ischemia, latent TB treatment, and pediatric migraine prevention. Most are hypothesis-generating or confirmatory; none appear immediately practice-changing based on available descriptions alone.
Pediatric and Adolescent Oncology
Phase I RCT of web-based physical activity intervention in children and adolescents with cancer posted results.So what: Phase I focus is safety and feasibility, not efficacy; hypothesis-generating at best, no practice change yet.
Diabetes Management
FINANCE-DM tested financial incentives added to nurse coaching for improving type 2 diabetes outcomes.So what: Behavioral economics approach is intriguing but evidence is thin until full results and effect sizes are reviewed.
Aging and Rehabilitation Technology
Smart-technology intervention aimed to reduce COVID-19-related disability in rural older adults posted results.So what: Hypothesis-generating for telehealth and remote monitoring in underserved elderly; broader applicability depends on effect size.
Video-based movement tracking measured post-stroke walking improvements from clinic to home setting.So what: Novel gait-monitoring tool; early stage, focused on measurement validity rather than treatment outcomes.
Urology
Multi-site RCT compared cyclic versus continuous sacral neuromodulation for overactive bladder syndrome.So what: Could refine programming protocols for sacral neuromodulation; await full outcome data before changing practice.
Cardiology
Study examined sex differences in mental-stress-induced myocardial ischemia after MI and prognostic implications.So what: Hypothesis-generating for sex-specific post-MI risk stratification; mental stress ischemia remains underrecognized clinically.
Infectious Disease
TBTC Study 35 evaluated rifapentine formulations with isoniazid for latent tuberculosis treatment.So what: Could support simplified short-course latent TB regimens; results warrant attention given public health impact.
Pediatric Neurology
RCT assessed long-term safety and tolerability of subcutaneous fremanezumab for migraine prevention in children and adolescents.So what: CGRP-pathway agents lack strong pediatric evidence; safety data here are valuable but efficacy conclusions need full review.
Phase distribution · 232 recent trials with a stated phase
Regorafenib and Durvalumab for the Treatment of High-Risk Liver CancerStage IB Hepatocellular Carcinoma AJCC v8, Stage II Hepatocellular Carcinoma AJCC v8, Stage III Hepatocellular Carcinoma · Phase 2 · ACTIVE_NOT_RECRUITING · Academic and Community Cancer Research United · 2026-07-20
Living Memory Home-4-Dementia Care PairsDyadic Family Caregiver-person With Dementia Online Intervention · N/A · COMPLETED · Weill Medical College of Cornell University · 2026-07-22
Sleep Treatment for TeensSleep Problem, Suicidal Ideation, Suicide, Attempted · N/A · COMPLETED · Rutgers, The State University of New Jersey · 2026-07-08
Brain Health in MidlifeBrain Health, Gestational Hypertension, Alzheimer Disease, Dementia · COMPLETED · University of Kansas Medical Center · 2026-07-14
Accelerated rTMS for Post-Stroke ApathyApathy, Stroke Sequelae, Stroke (CVA) or TIA, Stroke/Brain Attack · Phase 1 · COMPLETED · Medical University of South Carolina · 2026-07-10
Uric Acid Lowering Trial in Youth Onset T2DDiabetic Kidney Disease, Hyperuricemia, Diabetes, Diabetes Mellitus, Type 2 · Phase 2 · COMPLETED · University of Colorado, Denver · 2026-07-28
Siplizumab in T1DMType 1 Diabetes Mellitus · Phase 1, Phase 2 · TERMINATED · National Institute of Allergy and Infectious Diseases (NIAID) · 2026-07-28
Esketamine Induction Intubation in ICU Patients.Critically Ill Patients · Early Phase 1 · COMPLETED · Union Hospital, Tongji Medical College, Huazhong University of Science and Techn · 2026-07-21