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  • Three deaths in China’s investigator-initiated trials raise concerns over fast, low-cost clinical testing
    Three participants died while taking part in investigator-initiated trials in China, prompting renewed scrutiny of the country’s clinical testing practices. China’s system is prized for its low co…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 1d agoApprovalPositive↗ source
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  • Eli Lilly teams with Amplitude on taRNA vaccine platform as Otsuka ends psychedelic trial
    Eli Lilly announced a collaboration with Amplitude Therapeutics to co‑develop vaccine candidates using a trans‑amplifying RNA (taRNA) platform. The taRNA approach aims to boost antigen expression…
    Endpoints · 1d agoDealNeutral↗ 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 · 1d agoRegulatoryNegative↗ source
  • Chai Discovery partners with Bristol Myers Squibb to use AI for antibody discovery
    Chai Discovery, an AI-driven drug discovery company, announced a collaboration with Bristol Myers Squibb to apply its artificial-intelligence models to therapeutic antibody research. The partnershi…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Eli Lilly partners with Amplitude Therapeutics to develop trans-amplifying RNA vaccines for infectious diseases
    Eli Lilly announced a collaboration with Boston-based Amplitude Therapeutics, a company that emerged from Lilly’s Gateway Labs incubator. The partnership will focus on developing trans-amplifying…
    Fierce Biotech · 1d agoDealPositive↗ 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 · 1d 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 · 1d agoPositive↗ source
  • FDA rejects Osteal Therapeutics' combo therapy for joint-implant infections
    The U.S. Food and Drug Administration rejected Osteal Therapeutics' lead combination therapy late last month. The agency cited concerns that prevented approval of the product intended to treat infe…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 1d agoApprovalPositive↗ source
  • 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 · 1d 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 · 1d agoNeutral↗ source
  • 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 · 1d agoNeutral↗ source
  • Neumora Therapeutics appoints Joshua Pinto as CEO and Doron Sagman as CMO ahead of IND filing
    Neumora Therapeutics announced leadership changes, naming Joshua Pinto, Ph.D., as its new chief executive officer. Pinto, who joined Neumora in 2021 as chief financial officer and most recently se…
    Fierce Biotech · 1d agoNeutral↗ source
  • Pheast Therapeutics sticks with open R&D despite competitor Antengene moving ahead with anti‑CD24 trials
    Pheast Therapeutics, a Redwood City biotech founded in 2021, builds on Irv Weissman’s 2019 Nature paper that highlighted the CD24 protein as a promising "don’t eat me" target for cancer immunothera…
    Fierce Biotech · 1d 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 · 1d 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 · 1d agoDealNeutral↗ source
  • Boehringer Ingelheim pauses phase 1 trial of BI 3031185 in Japan to investigate safety event
    Boehringer Ingelheim has placed a phase 1 study of its investigational oral small‑molecule candidate BI 3031185 on voluntary hold after a safety event was reported. The trial, which began in early…
    Fierce Biotech · 1d agoCRLNeutral↗ 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 2d 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 · 2d 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 · 2d agoApprovalPositive↗ source