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  • Trump administration nominates Heidi Overton as FDA commissioner after acting chief declines
    The White House announced that Heidi Overton has been nominated to lead the Food and Drug Administration after acting commissioner Kyle Diamantas turned down a permanent appointment. Reports from…
    STAT · 19d agoRegulatoryNeutral↗ source
  • American Cancer Society cancels wine and spirits gala amid conflict-of-interest concerns
    The American Cancer Society announced it will not hold the planned Wine and Spirits Industry Gala after internal review highlighted a conflict of interest with the alcohol sector, which is linked t…
    STAT · 19d agoNeutral↗ source
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  • PhRMA weighs former Republican lawmakers and Trump administration officials for CEO role
    PhRMA, the pharma lobbying group, has been searching for a new chief executive for over four months. The search has focused on candidates with Republican backgrounds, including former members of C…
    Endpoints · 19d agoNeutral↗ source
  • Experts call for modernizing rare disease evidence models using FDA plausible mechanism framework
    A recent paper in The Journal of Clinical Investigation argues that the evidentiary approach for rare diseases needs updating. The authors suggest applying the FDA’s plausible mechanism framework,…
    raps · 19d agoNeutral↗ source
  • FDA expands TEMPO pilot with new digital health partners Limbic, Cadence and Dexcom
    The FDA is quietly building a pilot program called TEMPO to test a “try first, evaluate later” approach for digital health devices. The agency has added the behavioral‑health firm Limbic to the ro…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • WuXi Bio sells majority stake in chromatography resin maker Bestchrom; Cabaletta adds new CDMO partner
    WuXi Bio announced it will divest its 51.1% equity interest in Bestchrom, a Shanghai-based supplier of chromatography resins. The sale will transfer control to an unnamed third party, marking WuXi…
    Endpoints · 19d agoDealNeutral↗ source
  • Epic expands AI tools for clinicians and patients, intensifying competition for health-tech startups
    Epic highlighted its growing portfolio of artificial‑intelligence applications for both clinicians and patients at its annual Users Group Meeting in Verona, Wisconsin. The presentation showcased ne…
    Endpoints · 19d agoNeutral↗ source
  • US allocates $2 billion to faith-based health groups, highlighting shift toward faith-driven capital in global aid
    The Trump administration this month announced a nearly $2 billion allocation for faith‑based organizations, the largest such commitment in over two decades. About $1.4 billion is earmarked for hea…
    STAT · 19d agoNeutral↗ source
  • EMA launches consultation on draft framework to speed adoption of data standards
    EMA has opened a public consultation on a draft framework aimed at accelerating the implementation of data standards across the pharmaceutical sector. The agency says the new framework is intended…
    raps · 19d agoRegulatoryNeutral↗ source
  • Experts warn protein restriction could harm older adults and GLP-1 patients
    Researchers have recently suggested that limiting dietary protein might improve metabolic health and extend lifespan, a claim highlighted in a review paper in Cell Press Blue. Nutrition specialist…
    STAT · 19d agoNegative↗ source
  • Experts urge DSM to list muscle dysmorphia as eating disorder to improve care for men
    Males account for roughly one third of people in the United States who struggle with eating disorders, and many of these conditions begin in the teenage years. Some estimates suggest that as many a…
    STAT · 19d agoNeutral↗ source
  • FDA approves Regeneron’s garetosmab for ultra-rare bone-forming disease
    The FDA has granted approval to Regeneron's antibody garetosmab, which targets activin A, for the treatment of fibrodysplasia ossificans progressiva (FOP). FOP is an ultra‑rare disorder that causes…
    Endpoints · 20d agoApprovalPositive↗ source
  • Merck and Moderna report success in late-stage trial of personalized mRNA cancer vaccine
    Merck and Moderna announced that their personalized mRNA cancer vaccine achieved its primary endpoint in a randomized late-stage trial, marking the first demonstration that such an approach can be…
    STAT · 20d agoPositive readoutPositive↗ source
  • Regeneron's Pasatru receives FDA approval for ultra-rare bone-growth disease FOP
    Regeneron Pharmaceuticals has secured FDA approval for Pasatru, a therapy aimed at treating fibrodysplasia ossificans progressiva (FOP), an ultra‑rare condition in which bone forms in soft tissues.…
    STAT · 20d agoApprovalPositive↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 20d agoPositive readoutPositive↗ source
  • Merck and Moderna report personalized mRNA vaccine delays melanoma recurrence in late-stage trial
    Merck and Moderna announced that a personalized mRNA cancer vaccine, when combined with standard therapy, slowed the return of melanoma and reduced its spread in a late-stage clinical study. The tr…
    STAT · 20d agoPositive readoutPositive↗ source
  • Merck and Moderna report Phase 3 success for personalized mRNA cancer vaccine intismeran autogene
    Merck and Moderna announced on August 19, 2026 that their personalized mRNA cancer vaccine, intismeran autogene, has completed a successful Phase 3 trial. The collaboration aims to create a patient…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • Moderna and Merck report success for personalized mRNA vaccine in late-stage melanoma trial
    Moderna and Merck announced that their personalized mRNA cancer vaccine succeeded in a late-stage melanoma study. The vaccine, called intismeran, was evaluated in a randomized Phase 3 trial, the fi…
    STAT · 20d agoPositive readoutPositive↗ source
  • Moderna cancer vaccine data lifts investor confidence, shares jump to multi-year highs
    Moderna has long said it wants to broaden its portfolio beyond infectious-disease vaccines. The company has been working on a cancer vaccine and investors have been waiting for late-stage trial res…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • Trump administration nominates Heidi Overton as FDA commissioner
    President Donald Trump has nominated Heidi Overton, the White House deputy director of domestic policy, to serve as the next commissioner of the Food and Drug Administration. Overton has been desc…
    STAT · 19d agoRegulatoryNeutral↗ source
  • Trump nominates Heidi Overton as FDA commissioner, known for criticism of vaccine mandates and abortion pills
    President Donald Trump announced Heidi Overton as his nominee for FDA commissioner, marking the start of a new chapter for the agency. Overton has previously voiced criticism of vaccine requiremen…
    Endpoints · 20d agoRegulatoryNeutral↗ source
  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 20d agoRegulatoryNeutral↗ source
  • Trump administration expected to nominate White House policy aide Heidi Overton as FDA commissioner
    President Donald Trump is expected to put forward White House deputy director of domestic policy Heidi Overton as the next commissioner of the U.S. Food and Drug Administration, according to STAT.…
    STAT · 20d agoRegulatoryNeutral↗ source
  • Biokin's EGFR-HER3 bispecific ADC succeeds in late-stage Chinese lung cancer trial
    Chinese biotech Biokin announced that its EGFRxHER3 bispecific antibody-drug conjugate met its primary endpoint in a late-stage trial in a genetically defined subset of non-small cell lung cancer (…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • AI fuels a parallel, unregulated medical ecosystem outside traditional care
    Arya Rao, a Harvard‑MIT M.D.-Ph.D. candidate, and Marc Succi, a Harvard radiology professor, argue that financial incentives are pulling major AI firms into health care, creating a shadow system se…
    STAT · 20d agoNegative↗ source