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94 stories matching this filter · ← front page

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  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 21h agoApprovalPositive↗ source
  • Merck/Moderna vaccine and Summit/Akeso bispecific therapy among key highlights at ESMO 2026
    The European Society of Medical Oncology (ESMO) meeting in Madrid this weekend will showcase several high‑profile oncology programs. Among the most watched are Merck and Moderna’s personalized can…
    BioSpace · 1d agoNeutral↗ source
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globenewswire health73
fda press51
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Psychiatry & CNS1104
Ophthalmology843
Endocrinology & Metabolism686
Pain650
Nephrology633
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 4d agoLayoffsNegative↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 5d agoApprovalPositive↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 5d agoRegulatoryPositive↗ source
  • GSK to cut over 1,200 jobs at Belgian sites as $2.5 bn restructuring continues
    GSK announced it will eliminate more than 1,200 positions across its Belgian facilities, following an earlier closure of a German vaccine plant that cut about 650 jobs. The reductions are part of…
    BioSpace · 5d agoLayoffsNegative↗ source
  • BioNTech's head and neck cancer mRNA vaccine fails to extend progression-free survival in Phase 3 trial
    BioNTech reported that its experimental mRNA immunotherapy BNT113 did not meet its primary endpoint in a Phase 3 trial for a specific head and neck cancer, failing to improve progression-free survi…
    BioSpace · 6d agoNegative readoutNegative↗ source
  • GSK to invest $800 million in new biologics manufacturing hub in Pennsylvania
    GSK announced it will spend more than $800 million to expand its Upper Merion site near Philadelphia, adding biologics production capacity. The plan includes demolishing existing structures next y…
    BioSpace · 8d agoDealPositive↗ source
  • Novartis licenses Abogen’s mRNA CD19×CD3 engager in $575M upfront deal
    Abogen Biosciences saw its COVID vaccine miss the market, prompting questions about whether its mRNA platform could be leveraged for other therapies. Novartis agreed to pay $575 million up front f…
    BioSpace · 11d agoDealPositive↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 11d agoRegulatoryNeutral↗ source
  • Vaxcyte’s VAX-31 shows superior results in Phase 3, beating Pfizer and Merck’s pneumococcal vaccines and sparking $8 bn market hopes
    Vaxcyte reported that its investigational pneumococcal conjugate vaccine, VAX-31, met the co-primary endpoints in a Phase 3 trial, demonstrating non-inferiority to the existing shots from Pfizer an…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • CSL strikes up to $1.6B deal with Alentis for autoimmune drug with broad potential
    CSL will co-develop and co-promote Alentis Therapeutics' anti-claudin-1 therapy lixudebart for kidney and liver conditions, including primary sclerosing cholangitis and a systemic autoimmune diseas…
    BioSpace · 15d agoDealNeutral↗ source
  • FDA issues request for information on early-phase ibogaine trial design
    The FDA announced a request for information (RFI) to gather input on how to design early-phase clinical trials of ibogaine drug products. The agency is looking for comments on protocol elements su…
    fda press · 15d agoRegulatoryNeutral↗ source
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 18d agoApprovalPositive↗ source
  • FDA launches nationwide recruitment to broaden scientific and consumer representation on advisory committees
    The U.S. Food and Drug Administration announced a new nationwide effort to recruit qualified experts and consumer representatives for its advisory committees. The agency issued two Federal Register…
    fda press · 20d agoRegulatoryPositive↗ source
  • US charges two Indian nationals in counterfeit Ozempic distribution scheme
    The U.S. Attorney’s Office for the Middle District of Florida and the DOJ’s Criminal Division announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals, for…
    fda press · 20d agoRegulatoryNegative↗ source
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 21d agoApprovalPositive↗ source
  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 21d agoRegulatoryNeutral↗ source
  • 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 · 24d agoNeutral↗ source
  • US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump
    In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as…
    BioSpace · 25d ago↗ source
  • China’s $522 bn biotech push fuels US competition and partnership opportunities
    Chinese biotech is entering a rapid growth phase, with the government’s new five-year plan targeting about $522 billion in revenue by 2030 and aiming for at least 25% of first-in-class drugs worldw…
    BioSpace · 27d agoDealPositive↗ source
  • Federal Court Issues Consent Decree Halting Gold Star Distribution's FDA-Regulated Shipments Over Unsanitary Warehouse
    The U.S. District Court for the District of Minnesota entered a consent decree on Sept. 21, 2026 that permanently enjoins Gold Star Distribution, Inc. and its owner Bassam Abu Samrah from distribut…
    fda press · 26d agoRegulatoryNegative↗ source
  • FDA issues rule to allow non-animal testing methods for drug safety
    FDA issued a direct final rule that updates its regulations to clarify that non-animal methods may be used for safety testing of drugs and biological products before they are tested in humans. The…
    fda press · 29d agoRegulatoryPositive↗ source
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30
    The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
    fda press · 1mo agoRegulatoryNeutral↗ source