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1,536 stories matching this filter · ← front page

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  • FDA to require companies to notify agency of new food additives, creating public database
    The Health and Human Services Department announced a new policy that obligates manufacturers to inform the FDA when they introduce a new substance into human or animal food, and to explain how they…
    STAT · 8d agoRegulatoryNeutral↗ source
  • Calls to Ban Prior Authorizations Amid Hospital Job Cuts Highlight Health‑Care Policy Debate
    The Health Care Inc. newsletter from STAT highlighted a proposal to eliminate most prior authorizations, a requirement that insurers use to control drug spending. The suggestion comes from policy…
    STAT · 8d agoNeutral↗ source
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  • Sobi pens $580M deal for Innate’s skin cancer drug ahead of phase 3 push
    Sobi has bought into Innate Pharma’s vision for lacutamab, handing the French biotech $75 million upfront for the rights to market the anti-KIR3DL2 antibody for an aggressive skin cancer.
    Fierce Biotech · 8d agoDealNeutral↗ source
  • India tightens penalties for submitting false regulatory documents
    The Indian government has introduced stricter penalties for applicants who submit misleading, fake, or fabricated documents to regulatory authorities, prohibiting them from making further filing re…
    raps · 8d agoRegulatoryNeutral↗ source
  • States urged to use low-cost, scalable outreach for Medicaid enrollees facing 2027 eligibility changes
    States must begin notifying Medicaid beneficiaries about upcoming eligibility changes by September, as required by the One Big Beautiful Bill Act of 2025. The changes, set to take effect in 2027, i…
    STAT · 8d agoNeutral↗ source
  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 8d agoNeutral↗ source
  • Aspo Plc reports managers' transactions on August 10, 2026
    Aspo Plc disclosed that its managers executed transactions on August 10, 2026, as recorded in a filing. The filing does not provide details about the nature, size, or parties involved in the trans…
    globenewswire health · 8d agoNeutral↗ source
  • Novo Nordisk partners with Amazon Web Services to boost AI-driven drug discovery, opens London hub
    Novo Nordisk announced a partnership with Amazon Web Services aimed at using artificial intelligence to speed up the discovery of new medicines. The collaboration will see AWS become Novo Nordisk's…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Sanofi reports shortages of Myozyme and Nexviazyme for Pompe disease after FDA manufacturing warning
    Sanofi has warned that supplies of two medicines used to treat Pompe disease are running low. The company notified patient groups and physicians in the United States and Europe that the shortage af…
    STAT · 8d agoRegulatoryNegative↗ source
  • Taylor Fresh Foods recalls jalapeño-containing products over possible Salmonella contamination
    Taylor Fresh Foods announced a recall of finished products that contain jalapeño peppers after being notified of a voluntary recall by Coast Citrus Distributors due to potential Salmonella contamin…
    fda recalls · 9d agoRegulatoryNegative↗ source
  • NatureBest Precut & Produce recalls jalapeño-containing products over possible Salmonella contamination
    NatureBest Precut & Produce LLC announced a voluntary recall of food items containing jalapeño peppers supplied by Coast Citrus Distributors because of potential Salmonella contamination. The reca…
    fda recalls · 10d agoCRLNegative↗ source
  • Novo Nordisk CFO sees oral Wegovy rollout boosting outlook and remains upbeat on CagriSema
    Novo Nordisk's chief financial officer, Karsten Munk Knudsen, discussed the company's second‑quarter earnings and the progress of the oral Wegovy pill during a recent interview. He highlighted that…
    Fierce Biotech · 11d agoEarningsPositive↗ source
  • Replimune secures FDA accelerated approval for melanoma therapy Tudriqev
    Replimune announced that the FDA has granted accelerated approval to its melanoma therapy RP1, marketed as Tudriqev, after two earlier rejections and a third expedited review. The decision reflects…
    STAT · 11d agoApprovalPositive↗ source
  • BlossomHill and Latigo Biotherapeutics raise over 30% beyond IPO targets
    Two emerging biotech companies surpassed their initial public offering expectations on Friday, with both BlossomHill Therapeutics and Latigo Biotherapeutics raising at least 30% more capital than p…
    Fierce Biotech · 11d agoDealPositive↗ source
  • BioMarin halts development of BMN 401 after phase 3 miss
    BioMarin Pharmaceutical announced it is ending all work on its experimental enzyme replacement therapy BMN 401 following a late‑stage trial that did not meet one of two primary goals in patients wi…
    Fierce Biotech · 11d agoNegative readoutNegative↗ source
  • Ensoma cuts staff again to focus on lead gene therapy for rare immune disease
    Boston‑based biotech Ensoma announced another round of layoffs as it narrows its efforts to its sole clinical candidate, EN‑374, aimed at treating X‑linked chronic granulomatous disease (X‑CGD). E…
    Fierce Biotech · 11d agoLayoffsNegative↗ source
  • Active shooter incident forces CDC staff to shelter in place, highlighting ongoing threats to public health workers
    On August 8, 2025, the author was working in an office at the Centers for Disease Control and Prevention when a series of loud bangs sounded outside. A laboratory director reported that a neighbori…
    STAT · 11d agoNegative↗ source
  • FDA outlines inspection overhaul, proposes IND reforms, and greenlights a disputed cancer therapy
    FDA officials announced a plan to restructure the agency’s inspectional operations, aiming to make inspections more efficient and focused. The proposed changes include consolidating regional office…
    raps · 11d agoRegulatoryNeutral↗ source
  • NIH to restrict Pathways to Independence grants to U.S. citizens and permanent residents
    The National Institutes of Health announced plans to limit eligibility for its “Pathways to Independence” award to U.S. citizens, permanent residents, and non‑citizen nationals. The change would ba…
    STAT · 11d agoRegulatoryNegative↗ source
  • Roche launches cyclospora PCR tests as lettuce-linked outbreak spreads across 15 US states
    Roche Diagnostics announced the rollout of two new real-time PCR assays that detect the parasite Cyclospora cayetanensis. The launch comes as the CDC and FDA report that the cyclospora outbreak li…
    Fierce Biotech · 11d agoPositive↗ source
  • EMA releases updated guidance on drug shortage prevention plans
    The European Medicines Agency has published a revised guideline aimed at helping marketing authorisation holders develop and keep drug shortage prevention plans for their products. The new guidanc…
    raps · 11d agoRegulatoryNeutral↗ source
  • Lexunder’s Food to Live green powder recalled over possible Salmonella contamination
    Lexunder Inc., operating as Food to Live, announced a recall of its green powder products due to potential Salmonella contamination. The recall covers products sold nationwide in resealable pouche…
    fda recalls · 10d agoCRLNegative↗ source
  • Eli Lilly and Novo Nordisk win dismissal of antitrust suit by compound pharmacy
    A federal judge has thrown out an antitrust lawsuit filed by a compound pharmacy against Eli Lilly and Novo Nordisk. The decision clears the two companies of the alleged wrongdoing and removes a le…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Boston-born biotech founder Felix Wong launches AI-driven startup in California
    Felix Wong grew up near Boston, earned two degrees at Harvard and completed a post-doc at MIT before launching his biotech company in California. His startup applies artificial intelligence to ide…
    STAT · 11d agoNeutral↗ source
  • Third gender-affirming clinic settles with DOJ as Senate moves to hold Fauci in contempt
    A third clinic that provides gender-affirming services reached a settlement with the Department of Justice, ending a federal investigation into alleged civil-rights violations. The agreement inclu…
    STAT · 11d agoRegulatoryNeutral↗ source