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  • 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 · 14h 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 · 19h agoNeutral↗ source
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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 · 1d 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 · 19h 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 · 19h agoNeutral↗ source
  • FDA finalizes Q&A guidance on developing cell and gene therapies
    The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to the development of cellular and gene therapy (CGT) products.
    raps · 1d ago↗ 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoPositive readoutPositive↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump announced his intent to nominate Heidi Overton, M.D., Ph.D., a current White House aide, to lead the Food and Drug Administration. Overton earned her medical degree from the…
    Fierce Biotech · 1d agoRegulatoryNeutral↗ source
  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 1d agoDealPositive↗ 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 · 1d agoNegative↗ source
  • Accrediting body weighs dropping explicit racism language from public health curriculum standards
    The Council on Education for Public Health is reviewing its core competency language for accredited schools. Currently the standards require students to discuss how structural bias, social inequit…
    STAT · 1d agoRegulatoryNegative↗ source
  • Federal appeals court revives portion of Teva's Medicare price-negotiation lawsuit amid Austedo discount plans
    Federal appeals court in the D.C. Circuit issued a decision Tuesday that partially overturns a lower‑court ruling that had dismissed Teva's challenge to Medicare's drug pricing negotiations. The r…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Trump expected to nominate Heidi Overton as new FDA commissioner
    President Donald Trump is expected to nominate Heidi Overton as the next commissioner of the U.S. Food and Drug Administration, according to a source familiar with the decision. Overton's selectio…
    Endpoints · 2d agoRegulatoryNeutral↗ source