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2,387 stories matching this filter · ← front page

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  • ARPA-H earmarks $160 million for custom gene-editing therapies, sparking debate on adequacy
    ARPA-H announced a $160 million investment to support development of bespoke gene‑editing treatments. This follows a recent case where an infant was rescued from a lethal disease using a personaliz…
    Endpoints · 1mo agoNeutral↗ source
  • HHS proposes new rule to compensate Covid-19 vaccine injury claims
    The U.S. Department of Health and Human Services has issued a proposed rule that would create a compensation mechanism for people who say they were injured by Covid-19 vaccines. The new system is…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
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  • Roche halts development of Huntington’s disease drug tominersen after ten years of trials
    Roche announced it is stopping work on tominersen, its experimental therapy for Huntington’s disease. The decision follows a Phase 2 study in which the drug performed no better than placebo. The c…
    Endpoints · 1mo agoNegative↗ source
  • UK regulator advises stopping reimbursement for Amgen's lung cancer drug Lumakras for new patients
    The National Institute for Health and Care Excellence (NICE) in the United Kingdom released draft guidance recommending that government reimbursement for Amgen’s lung cancer therapy Lumakras be dis…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA reprimands Lundbeck Seattle Biopharmaceuticals for inflated claims on Vyepti migraine webpages
    The U.S. Food and Drug Administration issued an untitled letter to Lundbeck Seattle Biopharmaceuticals criticizing two promotional webpages about its migraine treatment Vyepti. The agency said the…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • GSK ends $2.2 billion brain drug partnership with Alector after trial failures
    GSK and California‑based biotech Alector have ended their collaboration after both experimental brain drugs failed to meet development milestones. The partnership, announced in July 2021, gave GSK…
    BioPharma Dive · 1mo agoDealNegative↗ source
  • FDA pauses public release of Complete Response Letters to limit litigation risk
    The FDA announced it has temporarily halted the routine public posting of Complete Response Letters (CRLs), which are letters sent to drug sponsors when the agency does not approve a marketing appl…
    Endpoints · 1mo agoCRLNeutral↗ source
  • Michigan sees nearly 1,000 cyclospora cases, the state's largest outbreak and among the nation's biggest
    Nearly a thousand residents of Michigan have been diagnosed with a cyclospora infection that causes prolonged watery diarrhea, making it the biggest outbreak in the state's history and one of the l…
    STAT · 1mo agoNeutral↗ source
  • ARPA-H launches $160 million THRIVE program to fund seven labs developing custom gene-editing therapies for rare diseases
    ARPA-H, the U.S. Advanced Research Projects Agency for Health, announced a new initiative called THRIVE with up to $160 million in funding. The program will support seven research teams over five…
    STAT · 1mo agoPositive↗ source
  • Ipsen's Dysport shows positive Phase 3 results in migraine, Tarsus acquires iRenix for $75M
    Ipsen reported that its injectable neurotoxin Dysport met the primary endpoint in a Phase 3 trial aimed at reducing monthly migraine days. The trial demonstrated a statistically significant reduct…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • White House reviews three candidates to lead the FDA
    STAT+ reports that the White House is currently evaluating three leading candidates to become the next head of the Food and Drug Administration. The review process is part of the administration's e…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Mid-year roundup highlights top health-tech trends in 2026
    The editorial team notes that the first half of 2026 has been unusually active for health technology. Five major developments have been identified as the most significant so far. One clear theme i…
    Endpoints · 1mo agoNeutral↗ source
  • Podcast discusses health insurance costs, whistleblower case, and potential FDA commissioner picks
    The Readout LOUD podcast episode explores why employer-provided family health insurance can be as expensive as a new car. The hosts interview a whistleblower who challenged an insurance contractor…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • STAT+: Prime wins Beam arbitration, clearing path to clinic
    AstraZeneca, Ionis report major trial failure, White House pushes for American drug manufacturing, and more biotech news from The Readout
    STAT · 1mo ago↗ source
  • Eli Lilly dominates first-half biotech acquisitions, with no sign of slowing down
    Riding on its trillion-dollar heft and successes in treating obesity, Eli Lilly has now become a force in one area where it hasn’t historically been the main player: M&A. The Indianapolis-based dru…
    Endpoints · 1mo ago↗ source
  • Catalent to divest UK site; Rottendorf, Evonik announce manufacturing builds
    Plus, news about RoslinCT, Novo Nordisk and more. 🇬🇧 Catalent to sell UK site to Codis: The CDMO is set to take Catalent’s oral solid dose factory in Nottingham, with ...
    Endpoints · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about FDA commissioner contenders, a heart drug failure, and more
    The White House is reviewing a list of three top contenders for the FDA commissioner post
    STAT · 1mo ago↗ source
  • STAT+: OpenEvidence backs study that finds it beats LLMs
    In this edition of STAT Health Tech: Dueling research pitting OpenEvidence against general purpose LLMs, use of Dexcom's CGM in children, and more.
    STAT · 1mo ago↗ source
  • HHS plan to speed drug research won’t remove ‘self-inflicted’ delays
    U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?
    BioPharma Dive · 1mo ago↗ source
  • AstraZeneca, Ionis drug fails big heart disease study in major setback
    Eplontersen’s failure in transthyretin-mediated amyloidosis cardiomyopathy caught Wall Street analysts by surprise and boosted the outlook of rival drugs from Alnylam and BridgeBio Pharma.
    BioPharma Dive · 1mo ago↗ source
  • Who’s going to run the FDA?
    RFK Jr.'s list of Covid vaccine injuries, a father's quest to cure his daughter, and more health news from Morning Rounds
    STAT · 1mo ago↗ source
  • GSK walks away from Alector pact as immuno-neurology bet fizzles
    After two high-profile trial failures over the past year, GSK is breaking off a deal that features $700 million upfront that it signed with Alector for neurodegenerative disease treatments. GSK’s e…
    Endpoints · 1mo ago↗ source
  • STAT+: 931 days. The drug approval scandal hiding in plain sight
    Two years, six months, and 18 days have elapsed since Northwest Biotherapeutics submitted its brain cancer treatment for regulatory approval.
    STAT · 1mo ago↗ source
  • STAT+: AstraZeneca, Ionis report major trial failure with heart disease drug
    AstraZeneca and Ionis reported a notable trial failure Thursday in a heart disease that's become an increasingly competitive market for drugmakers.
    STAT · 1mo ago↗ source