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3,568 stories matching this filter · ← front page

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  • Sanofi’s Pompe disease enzyme therapy clears Phase 3 in infants, opening US label expansion
    Sanofi announced that its next‑generation enzyme replacement therapy for Pompe disease met its primary endpoints in a registrational Phase 3 trial involving infants with the severe infantile‑onset…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • BeOne’s Brukinsa cuts risk of progression or death by 43% in frontline mantle cell lymphoma Phase 3 trial
    BeOne Medicines reported that its BTK inhibitor Brukinsa achieved a significant benefit in a Phase 3 trial for patients with mantle cell lymphoma who received the drug as first‑line therapy. The s…
    Endpoints · 4mo agoPositive readoutPositive↗ source
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  • NIH's All of Us program taps clinical data-sharing networks to add thousands of EHR records
    The National Institutes of Health's All of Us research program announced a new method for gathering real-world health data by leveraging existing patient data-sharing networks that are typically us…
    STAT · 4mo agoPositive↗ source
  • House panel launches probe into Bristol Myers and Pfizer's China trial sites
    A congressional committee has opened an inquiry into the use of clinical trial sites in China by Bristol Myers Squibb and Pfizer. The panel is focusing on facilities that the committee chair says…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Anthropic to launch its own drug-development program using Claude Science AI
    Anthropic, an AI company best known for its Claude models, announced it will begin developing its own drug candidates. Executives said the effort is meant to give the firm hands-on experience appl…
    STAT · 4mo agoPositive↗ source
  • FDA picks seven firms, including Eli Lilly and Fujifilm, for PreCheck pilot to speed factory inspections
    The FDA announced that it has selected seven companies to join the inaugural PreCheck pilot, a program designed to accelerate the review of manufacturing facilities. The cohort includes large drug…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • AbbVie and Genmab's Epkinly shows positive combo results, moving toward label expansion in DLBCL
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a successful outcome when tested together with a commonly used cancer therapy. The data indicate that the combination was…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Uganda reports Marburg cases, adding to regional Ebola crisis
    Uganda has informed the World Health Organization of a Marburg virus outbreak in its western region, confirming at least one case, with some sources indicating two cases. The emergence of Marburg,…
    STAT · 4mo agoNegative↗ source
  • Sarepta receives FDA decision deadline for exon-skipping therapies, appoints Anna Protopapas as Flare CEO
    The U.S. Food and Drug Administration has set a deadline for a decision on Sarepta Therapeutics' exon‑skipping drug program, with the agency expected to rule by the end of February. The timing is…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Investors increase stakes in Bain-backed biotech startup as FDA gene‑therapy chief departs
    Investors are putting more money into a biotech startup backed by private‑equity firm Bain Capital, according to the STAT+ newsletter. Vijay Kumar is leaving his role as acting director of the FDA…
    STAT · 4mo agoDealNeutral↗ source
  • US lawmakers probe Chinese clinical trial sites for potential military links involving major drugmakers
    A bipartisan group of U.S. lawmakers has launched a national‑security investigation into whether several large pharmaceutical companies participated in clinical trials at Chinese sites that may hav…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problems
    Unicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time. The FDA c…
    Endpoints · 4mo agoCRLNegative↗ source
  • Beeline Medicines secures $126M from Bain Capital, CPPIB and Bristol Myers to expand immunology pipeline
    Beeline Medicines, a spinout from Bristol Myers Squibb, announced it has received an additional $126 million in financing. The new capital comes from existing investors Bain Capital and the Canada…
    Endpoints · 4mo agoDealPositive↗ source
  • Trump drug deal with Eli Lilly and Novo Nordisk has loophole allowing higher GLP-1 volumes without price cuts
    The Trump administration negotiated a "grand bargain" with drugmakers that promised lower Medicare and Medicaid prices for GLP‑1 drugs in exchange for higher sales volume. Eli Lilly and Novo Nordi…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Abivax's new ulcerative colitis data eases safety worries, sending shares up 25%
    Abivax released additional data on its experimental ulcerative colitis drug obefazimod. Earlier trial results had shown strong efficacy but raised safety concerns after several cancer cases were r…
    STAT · 4mo agoPositive readoutPositive↗ source
  • FDA reviewers recommend against adding seven peptides to bulk drug list for compounding
    FDA reviewers have advised that seven widely used peptides should not be added to the FDA's bulk drug substance list for compounding. Their recommendation comes before an upcoming advisory committe…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Anthropic launches Claude Science AI platform tailored for pharmaceutical research
    Anthropic announced the availability of Claude Science, an AI application built on its large language model and aimed at scientific laboratories and pharmaceutical research. The tool is intended t…
    STAT · 4mo agoPositive↗ source
  • Abivax reports ulcerative colitis trial cancer rates align with expectations
    Abivax released new data from its Phase 3 trial of an ulcerative colitis candidate. The data show that the number of cancer cases observed was within the range normally expected for ulcerative col…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Anthropic launches Claude Science, AI platform aimed at bioscience and drug discovery
    Anthropic, known for its Claude Code AI coding assistant, announced a new product called Claude Science aimed at the life‑science sector. The platform is designed to help biopharma researchers wit…
    Endpoints · 4mo agoPositive↗ source
  • FDA digital chief signals upcoming AI regulatory guidance
    STAT+ health-tech newsletter reported that the FDA’s digital leader offered a preview of forthcoming guidance on artificial intelligence. The briefing, delivered by Rick Abramson, highlighted the a…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Half of U.S. states file lawsuits challenging Medicaid work-requirement rules
    A coalition of states has filed legal challenges against recent Medicaid work‑requirement policies, arguing that the rules threaten access to health coverage for low‑income residents. The lawsuits…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Trump administration downplays alcohol risks, hindering efforts to curb drinking-related harms
    A STAT investigation reported that the Trump administration has downplayed the health risks of alcohol and has taken steps that obstruct research into drinking-related harms. Although alcohol is r…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Health tech executives grow confident in AI, survey shows sharp shift in attitudes
    A yearly survey conducted by Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan Mangini reveals that confidence in using artificial intelligence within healthcare has risen sharply over t…
    Endpoints · 4mo agoPositive↗ source
  • Rep. Tom Kean Jr. Discloses Depression Diagnosis After Four-Month Congressional Absence
    Rep. Tom Kean Jr., a Republican congressman from New Jersey, announced on the House floor that he has been receiving treatment for depression, which explains his unexplained four-month absence from…
    STAT · 4mo agoNeutral↗ source
  • Virtual mental-health firms accelerate AI chatbot development using therapy session data
    People are turning to artificial intelligence for daily tasks, companionship and emotional support, prompting virtual mental‑health providers to explore AI solutions. Companies that were previousl…
    Endpoints · 4mo agoNeutral↗ source