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2,118 stories matching this filter · ← front page

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  • House passes FDA Modernization Act 3.0 to push update of animal testing regulations
    The U.S. House approved the FDA Modernization Act 3.0, a bill aimed at modernizing preclinical testing rules. The legislation requires the FDA to revise regulations that still reference animal tes…
    Fierce Biotech · 22d agoRegulatoryPositive↗ source
  • Vertex pays second-highest M&A premium as sole bidder for Crinetics
    Vertex Pharmaceuticals emerged as the only bidder for Crinetics Pharmaceuticals, aiming to acquire the company. The bid involved a premium that ranks as the second-highest in the biopharma sector…
    Endpoints · 22d agoDealNeutral↗ source
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  • Science Corp's retinal implant gains European approval, eyesight aid for macular degeneration patients
    Science Corporation announced that European regulators have approved its retinal implant for patients with age-related macular degeneration. The device, described as a 'cochlear implant for vision…
    STAT · 22d agoApprovalPositive↗ source
  • Royalty Pharma pays $125M upfront for royalty stake in AstraZeneca’s ATTR drug cliramitug
    Royalty Pharma has entered a deal to acquire a royalty interest in a transthyretin amyloidosis drug being developed by AstraZeneca. The agreement involves an upfront payment of $125 million to Neu…
    Fierce Biotech · 22d agoDealPositive↗ source
  • Maui wildfire study proposes new rural health model for disaster recovery
    Researchers Alika Maunakea and Ruben Juarez are leading one of the largest investigations into the long‑term health effects of the 2023 Lahaina wildfires. The study follows more than 20 participant…
    STAT · 22d agoPositive↗ source
  • Survey Finds 24% of U.S. Workers Stay in Unwanted Jobs to Keep Health Insurance
    A Gallup and West Health survey of more than 2,000 employed adults found that 24% would stay in a job they dislike simply to retain health insurance coverage. The phenomenon, known as job lock, ha…
    STAT · 22d agoNegative↗ source
  • Study finds Merck’s Ervebo may protect against Bundibugyo Ebola strain, prompting calls for DRC testing
    New data from a human study published in the New England Journal of Medicine suggests Merck's Ervebo vaccine, licensed for the Zaire ebolavirus, may also offer protection against the Bundibugyo spe…
    STAT · 22d agoPositive readoutPositive↗ source
  • Arrowhead's gene-silencing therapy shows strong results in two late-stage triglyceride trials
    Arrowhead Pharmaceuticals reported positive data from its lipid-lowering gene-silencing candidate Redemplo in two late-stage studies. The results suggest the therapy effectively reduces triglyceri…
    Endpoints · 22d agoPositive readoutPositive↗ source
  • Pharma pushes back on China restrictions as AI VC raises $800M and Merck unveils cholesterol pill; Celldex reports trial setback
    Pharma companies are working to ease the impact of broad new restrictions in China, seeking ways to maintain market access amid tighter regulatory scrutiny. An AI‑focused venture capital firm anno…
    STAT · 22d agoNeutral↗ source
  • Hospital AI oversight lagging; senior leaders must take daily responsibility
    AI tools are now common in U.S. hospitals, handling tasks such as drafting clinical notes, flagging sepsis, screening imaging, processing prior authorizations, and responding to patient messages.…
    STAT · 22d agoNeutral↗ source
  • Celldex halts skin disease program after barzolvolimab fails phase 2 trial
    Celldex Therapeutics announced it is discontinuing development of its anti‑KIT antibody barzolvolimab for chronic skin disorders after the drug failed to meet its primary endpoint in a phase 2 stud…
    Fierce Biotech · 22d agoNegative readoutNegative↗ source
  • FDA moves to reverse policies of former commissioner Marty Makary
    The Trump administration is actively rolling back decisions made under former FDA commissioner Marty Makary. As the White House weighs a new nominee for the agency, officials have begun revisiting…
    Endpoints · 22d agoRegulatoryNegative↗ source
  • Study finds rising job dissatisfaction and health‑care access uncertainty among U.S. workers
    A new study shows increasing levels of job dissatisfaction and uncertainty about health‑care access among U.S. workers. The research, funded by AHRQ, surveyed a national sample and found that a gr…
    STAT · 22d agoNegative↗ source
  • AHRQ cuts $109 million in health services research grants, ending 78 projects early
    AHRQ announced that dozens of health services research grants will stop early, affecting about $109 million still to be spent. The agency said it is reshaping its discretionary award portfolio to…
    STAT · 22d agoRegulatoryNegative↗ source
  • Former FDA oncology chief calls for agency restructuring after recent staff cuts
    Richard Pazdur, who led the FDA’s Oncology Center of Excellence for more than twenty years, said the agency now faces a "golden opportunity" to restructure its operations. He made the comments aft…
    Endpoints · 22d agoRegulatoryNeutral↗ source
  • Nabla executive Alex LeBrun discusses ‘world model’ AI as an alternative to large language models
    Brittany Trang of STAT’s AI Prognosis newsletter interviewed Alex LeBrun, the executive chairman of AI scribe company Nabla, to explore a concept called a “world model.” LeBrun described a world m…
    STAT · 22d agoNeutral↗ source
  • Argentina’s World Cup defeat offers a cautionary lesson for U.S. hospitals on avoiding complacency
    Opinion writer Basel Tarab, a physician and hospital administrator, reflects on Argentina’s recent World Cup loss as a metaphor for American health‑care systems. He recalls Argentina’s 2022 triump…
    STAT · 22d agoNeutral↗ source
  • FDA revokes Orange B color additive and proposes to drop Citrus Red No. 2 from food approvals
    The U.S. Food and Drug Administration issued a final order that revokes the authorized use of Orange B as a food color additive. The agency also proposed revoking Citrus Red No. 2, a pigment autho…
    fda press · 22d agoRegulatoryNeutral↗ source
  • Gilead and Merck to unveil detailed Phase 3 results of once‑weekly oral HIV regimen at AIDS 2026; Dimension Capital launches $800M fund
    Gilead Sciences and Merck announced that they will present detailed results from their Phase 3 trials of a once‑weekly oral HIV treatment regimen at the upcoming AIDS 2026 conference. The data wil…
    Endpoints · 23d agoNeutral↗ source
  • Agios halts sickle cell drug program after disappointing phase 2 results
    Agios announced it is stopping development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a phase 2 trial failed to meet expectations. The study enrolle…
    Fierce Biotech · 23d agoNegative readoutNegative↗ source
  • FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study
    The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
    Endpoints · 23d agoRegulatoryNegative↗ source
  • Biotech firms rally to defend FDA's mifepristone approval in Louisiana lawsuit
    Biotech companies, executives and investors filed an amicus brief supporting the FDA in the Louisiana case that seeks to limit access to the abortion pill mifepristone. The brief is signed by 61 e…
    Fierce Biotech · 23d agoRegulatoryPositive↗ source
  • FDA to appoint permanent heads of CBER and CDER alongside new commissioner
    The FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…
    Endpoints · 23d agoRegulatoryNeutral↗ source
  • Agios halts development of next‑generation sickle‑cell drug tebapivat after disappointing mid‑stage trial
    Agios Therapeutics announced it will discontinue development of tebapivat, a next‑generation therapy for sickle cell disease, after the drug failed to demonstrate sufficient efficacy in a Phase 2 t…
    Endpoints · 23d agoNegative readoutNegative↗ source
  • Broad Institute, Boston Children’s Hospital and Jackson Laboratory launch nonprofit to advance affordable gene therapies for rare diseases
    The Broad Institute, Boston Children’s Hospital and Maine’s Jackson Laboratory announced a new collaboration to develop gene‑based treatments for rare genetic disorders. The three institutions will…
    STAT · 23d agoDealPositive↗ source