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  • Regeneron’s ultra-rare bone disorder drug receives U.S. approval after 30-year development
    Regeneron Pharmaceuticals announced that its therapy for an ultra-rare condition in which bone forms in soft tissue has been approved by the U.S. Food and Drug Administration. The disease, sometim…
    STAT · 2h agoApprovalPositive↗ source
  • Merck and Moderna report positive late-stage melanoma vaccine results, adding to 2026 cancer breakthrough year
    Merck and Moderna announced that their personalized mRNA neoantigen vaccine achieved positive outcomes in a late-stage trial for melanoma patients. The data suggest the vaccine can stimulate an imm…
    STAT · 4h agoPositive readoutPositive↗ source
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  • FDA approves Ultragenyx gene therapy and Regeneron ultra-rare disease drug
    The Food and Drug Administration gave the green light to a gene‑therapy product from Ultragenyx, marking a new treatment option in the company’s pipeline. In a separate decision, Regeneron secured…
    STAT · 1h agoApprovalPositive↗ source
  • Capricor Therapeutics likely faces FDA rejection of its Duchenne cell therapy
    Capricor Therapeutics is working to avoid an imminent FDA rejection of its cell‑based treatment for Duchenne muscular dystrophy. The company says it remains confident in the drug, but the regulator…
    STAT · 4h agoRegulatoryNegative↗ source
  • Capricor’s Duchenne drug deramiocel receives negative FDA advisory vote on heart outcome
    Mindy Leffler, a parent of a young man with Duchenne muscular dystrophy, writes an opinion piece about Capricor’s phase 3 study of its drug deramiocel. She describes her son’s experience living ind…
    STAT · 6h agoRegulatoryNegative↗ source
  • Health systems deploy AI chatbots to streamline patient record review
    Several large health systems are rolling out generative AI chatbots that can query and summarize electronic medical records. Clinicians report that the tools save time and help uncover information…
    STAT · 6h agoPositive↗ 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 · 1h 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 · 6h agoNeutral↗ 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 · 6h 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 · 6h agoNeutral↗ source
  • Cancer vaccine win restores Wall Street’s faith in Moderna
    Moderna gained $45 billion in market value in a single day, a surge that brought the company’s stock to levels not seen since 2024 — and saddled it with expectations that may be tough to meet.
    BioPharma Dive · 7m ago↗ source
  • Ultragenyx, after setbacks, nabs first gene therapy approval
    The clearance of Genglycos for a rare glycogen storage disease gives Ultragenyx a sellable voucher and momentum ahead of an eagerly anticipated study readout.
    BioPharma Dive · 14m ago↗ source
  • STAT+: How a Trump loyalist got the FDA nomination
    What you need to know about Heidi Overton, and Erica Schwartz's first speech to CDC staff.
    STAT · 48m ago↗ source
  • Chai tees up Bristol Myers Squibb AI antibody discovery collab
    A month after Chai Discovery tied up a major $400 million series C funding round, the AI drug discovery firm has teamed up with Bristol Myers Squibb.
    Fierce Biotech · 5h ago↗ source
  • Lilly pens deal with Gateway Labs alumni Amplitude for RNA vaccine platform for infectious disease
    Eli Lilly has turned to one of its Gateway Labs residents to help the Big Pharma develop trans-amplifying RNA (taRNA) vaccines for infectious diseases.
    Fierce Biotech · 5h ago↗ source
  • Merck-Moderna cancer vaccine win spurs stock jump, speculation of Keytruda-like impact
    As the dust settles on phase 3 data that added $45 billion to Moderna’s market cap, analysts have begun to ask a question that could define cancer care in the coming years: Can use of the vaccine b…
    Fierce Biotech · 6h ago↗ source
  • Meet Aletta: The first FDA approved robotic blood draw device
    The FDA has approved Vitestro’s Aletta as the first standalone robotic device in the U.S. designed to draw blood without the need for hands-on human help.
    Fierce Biotech · 7h ago↗ 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 · 22h 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 · 22h agoApprovalPositive↗ 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
  • 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
  • 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 · 19h 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 · 23h 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
  • 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