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2,369 stories matching this filter · ← front page

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  • Biomanufacturers Redesign Processes to Blend Emergency Vaccine Readiness with Commercial Flexibility
    Manufacturers are overhauling their production methods to simultaneously improve rapid vaccine deployment for future health crises and maintain flexible, commercially viable manufacturing networks…
    BioSpace · 26d agoNeutral↗ source
  • ADARx raises $446 million in one of 2026's largest biotech IPOs as City Therapeutics plans its own listing
    ADARx Pharmaceuticals completed an initial public offering that raised about $446.3 million, exceeding the company’s original target. The shares were priced at $17 each, with 26.25 million shares…
    BioSpace · 26d agoDealPositive↗ source
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  • Five candidates vie for WHO director‑general role as agency faces US funding pullback and tighter global health budgets
    At least five candidates are in the running to become the next director‑general of the World Health Organization, a race analysts say could be the most consequential in the agency's recent history.…
    STAT · 26d agoNeutral↗ source
  • Veteran Russell Shilling leads new federal autism research initiative
    Russell Shilling, a Navy veteran and father of two sons with autism, has been appointed to lead the Advanced Research Projects Agency for Health's new autism project. The initiative is described a…
    STAT · 26d agoPositive↗ source
  • Tobacco companies submitted 175,000 largely duplicate comments to block FDA menthol cigarette ban
    Researchers at Rutgers University analyzed the public comment period for the FDA’s 2022 proposal to ban menthol cigarettes and found that out of 175,000 submissions, 97% were form letters and only…
    STAT · 26d agoRegulatoryNegative↗ source
  • Jury awards Nektar $90 million in damages after lawsuit over broken rezpeg partnership with Eli Lilly
    A jury in a US court has ordered Eli Lilly to pay Nektar Therapeutics $90 million after finding the pharma giant breached their collaboration on the experimental autoimmune drug rezpeg. Nektar and…
    BioSpace · 26d agoNegative↗ source
  • Experts say measles death counts are muddled by 'with' vs 'of' debate
    Public health scientists note that Pennsylvania reported two measles‑related deaths in August, but the county coroner described one infant as having died "with" measles rather than "from" the disea…
    STAT · 26d agoNeutral↗ source
  • Rakuten Medical appoints Hassan Danesi as chief medical officer, coming from Coherus Biosciences
    Rakuten Medical announced that Hassan Danesi will join the company as its new chief medical officer. The appointment was disclosed in a recent industry column. Danesi previously served as vice pre…
    STAT · 26d agoNeutral↗ source
  • Opinion: RFK Jr.’s use of the National Center for Health Statistics will add confusion to measles deaths count
    “A discrepancy between how federal and state public health officials determine measles deaths will only increase public confusion,” write Denys T. Lau and Jennifer D. Schoendorf.
    STAT · 26d agoNeutral↗ source
  • Federal judge overturns key disability protection law
    A federal judge has reversed a longstanding disability protection ruling, reducing the legal safeguards that favored community-based living over institutional care. The Justice Department had anno…
    STAT · 26d agoRegulatoryNegative↗ source
  • Opinion: FDA commissioner nominee Heidi Overton is ignoring the science on abortion drug
    “With this latest appointment, mifepristone has a new boss but an old problem,” writes Julie F. Kay, founder and CEO of Reproductive Futures.
    STAT · 26d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a reticent FDA commish nominee, a Novo deal, and more
    President Trump’s nominee to lead the FDA was grilled by senators on hot button topics like China, vaccines, and abortion access
    STAT · 26d ago↗ source
  • FDA approves Eli Lilly’s weekly insulin Onswik for U.S. patients, expanding competition with Novo
    The U.S. Food and Drug Administration has cleared Eli Lilly’s weekly insulin product, Onswik, for use in American patients. This marks the drug’s fourth global approval after earlier clearances in…
    BioSpace · 27d agoApprovalPositive↗ source
  • Kyverna reports one-year mobility gains and safety for CAR-T miv-cel in stiff-person syndrome, bolstering FDA filing plans
    Kyverna Therapeutics presented data from its Phase 2 KYSA-8 trial of miv-cel, a CAR-T therapy aimed at stiff-person syndrome (SPS). The study followed 26 patients for one year. At the one-year mar…
    BioSpace · 27d agoPositive readoutPositive↗ source
  • Heidi Overton, a New Mexico-born physician, nominated as FDA commissioner
    Heidi Overton grew up in Gallup, New Mexico, and as a college freshman expressed a desire to become a doctor and return to her small hometown. Her early ambition was highlighted in a 2007 intervie…
    STAT · 27d agoRegulatoryPositive↗ source
  • Roche signs up to $2 billion partnership with Atavistik to develop cardiometabolic drugs
    Roche announced a partnership with Atavistik Bio, a biotech focused on hematology, to pursue new small-molecule treatments for cardiovascular, renal and metabolic conditions. The agreement provide…
    BioSpace · 27d agoDealPositive↗ source
  • Eli Lilly earmarks up to $3.25 billion for partnership with InnoCare Pharma
    Eli Lilly announced an upfront payment of $100 million to Beijing‑based InnoCare Pharma to start work on drug candidates for five targets that have critical unmet medical needs. The agreement also…
    BioSpace · 27d agoDealNeutral↗ source
  • Radioligand therapy gains momentum as experts discuss expanding patient impact
    In a recent episode of the Denatured podcast presented by Curium, host Jennifer Smith-Parker spoke with Mike Patterson, CEO North America, and Sabine Brookman-May, Vice President and Head of Global…
    BioSpace · 27d agoPositive↗ source
  • FDA nominee Heidi Overton avoids taking positions in Senate hearing on vaccines, China and abortion
    Heidi Overton, President Trump’s pick to lead the Food and Drug Administration, appeared before the Senate health committee for a two hour hearing. Senators focused their questions on China, vaccin…
    STAT · 27d agoRegulatoryNegative↗ source
  • FDA warns Houston compounding pharmacy of unsanitary GLP-1 production risking contamination
    FDA issued a warning letter to Empower Clinic Services, operating as Empower Pharmacy, after inspectors found unsanitary conditions at its Houston compounding site. Inspectors observed that the ph…
    BioSpace · 27d agoRegulatoryNegative↗ source
  • Indonesian court strikes down patent evergreening amendment, signaling pushback on drug pricing tactics
    An Indonesian Constitutional Court ruled that a recent amendment allowing patent evergreening was unconstitutional, reinstating the original restriction that balances patent rights with public heal…
    STAT · 27d agoRegulatoryPositive↗ source
  • Acadia’s Alzheimer’s psychosis drug misses primary goal but advances on secondary data
    Acadia Pharmaceuticals reported that its investigational drug remlifanserin failed to meet the primary endpoint in the Phase 2 portion of the RADIANT trial for Alzheimer’s disease psychosis. The t…
    BioSpace · 27d agoNegative readoutNeutral↗ source
  • Kyverna reports durable responses in early cell therapy trial for autoimmune disease
    Kyverna Therapeutics announced new data from its cell therapy candidate targeting an autoimmune condition, marking progress toward a potential first‑in‑class product. The results showed that a not…
    STAT · 27d agoPositive readoutPositive↗ source
  • Merck’s eye-drug matches Lucentis in vision improvement but raises safety concerns
    Merck reported results from its Phase 2b/3 BRUNELLO trial of remigromig, a Wnt-pathway agonist for diabetic macular edema. The drug achieved non-inferior improvement in best-corrected visual acuit…
    BioSpace · 27d agoNegative readoutNegative↗ source
  • FDA nominee Heidi Overton pledges faster, more efficient regulation to keep pace with China
    During a Senate hearing, Heidi Overton was confirmed as the nominee to lead the U.S. Food and Drug Administration. She outlined her priorities for the agency. Overton said the FDA must move faster…
    STAT · 27d agoRegulatoryNeutral↗ source