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1,139 stories matching this filter · ← front page

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  • Roche reports up to 30% shrinkage of chronic MS lesions with fenebrutinib, eyes FDA approval
    Roche has filed for FDA approval of its BTK inhibitor fenebrutinib for both relapsing and primary progressive multiple sclerosis, after the agency accepted the submission. At the MSToronto2026 mee…
    Fierce Biotech · 8h agoPositive readoutPositive↗ source
  • Hologic acquires Spain’s Reveal Genomics to expand breast cancer genomic testing
    Hologic, a medical‑technology company, announced it will acquire precision‑oncology firm Reveal Genomics, based in Spain. Reveal Genomics develops advanced genomic diagnostic tests, notably the HE…
    Fierce Biotech · 15h agoDealPositive↗ source
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  • Astellas partners with AI Proteins on $400M computational drug discovery deal
    Astellas Pharma of Japan has entered a partnership with Boston based AI Proteins to apply its computational design platform to drug discovery. AI Proteins builds miniproteins from scratch using ar…
    Fierce Biotech · 8h agoDealPositive↗ source
  • Biotech reverse mergers surge in 2026, reaching highest level since 2021 as PIPE financing spikes
    Biotech companies are using reverse mergers to re‑enter public markets at a rate not seen since 2021, according to a J.P. Morgan report released in October 2026. In the first nine months of 2026,…
    Fierce Biotech · 14h agoDealPositive↗ source
  • Myriad Genetics sells prenatal testing business to Labcorp for $210 million
    Myriad Genetics announced it will divest its Prenatal Health testing division to Labcorp, receiving $210 million in cash. The transaction includes Myriad's Prequel, Foresight, SneakPeek and FirstG…
    Fierce Biotech · 15h agoDealNeutral↗ source
  • Amid bepirovirsen triumph, GSK quietly scraps trial of next-gen hep B therapy
    GSK may have cemented its hepatitis B credentials with Tuesday’s landmark FDA nod for its “functional cure” bepirovirsen, but the pharma continues to rethink its strategy for next-gen candidates.
    Fierce Biotech · 8h agoRegulatoryNeutral↗ source
  • FDA approves Hibsago, first antisense therapy for chronic hepatitis B
    The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…
    fda press · 22h agoApprovalPositive↗ source
  • Researchers develop tumor "avatar" model that predicts immunotherapy response with 93% accuracy
    Researchers at Elephas Biosciences, in collaboration with academic centers, created an ex vivo tumor "avatar" from patient biopsies to test how tumors respond to immunotherapy. They exposed 124 tu…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • AstraZeneca teams with Oracle on AI-driven clinical trials as FDA clears Haemonetics vascular closure system
    AstraZeneca announced a collaboration with technology firm Oracle to incorporate artificial intelligence into its clinical trial processes. The partnership aims to use Oracle's cloud and data analy…
    raps · 1d agoApprovalPositive↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 1d agoApprovalPositive↗ source
  • FDA releases final guidance on prescription-drug companion apps and software
    FDA issued final guidance that creates a clear framework for how drug makers can develop, distribute and label mobile applications that accompany prescription medicines. The document answers three…
    fda press · 1d agoRegulatoryNeutral↗ source
  • Rapport Therapeutics' Phase 2 Bipolar Mania Trial Meets Primary Endpoint, Though Effect Size Below Target
    Rapport Therapeutics reported that its phase 2 study of RAP-219 in bipolar mania met the primary endpoint, showing a statistically significant improvement on the Young Mania Rating Scale (YMRS) at…
    Fierce Biotech · 1d agoPositive readoutNeutral↗ source
  • EY report says MedTech growth driven by commercial leaders, AI and expanding into new care settings
    The latest EY Pulse of the MedTech Industry report looks at the period from 2025 through the first half of 2026. It finds that innovation has spurred more dealmaking and R&D spending, while artific…
    Fierce Biotech · 1d agoPositive↗ source
  • Pfizer halts phase 2 trial of CXCR5 antibody for immune thrombocytopenia
    Pfizer announced it is ending a phase 2 study of its CXCR5-targeting antibody PF-06835375 in patients with primary immune thrombocytopenia (ITP). The decision was described as a business decision a…
    Fierce Biotech · 1d agoCRLNegative↗ source
  • FDA issues import alert on Olympus endoscopic devices over quality violations
    The U.S. Food and Drug Administration has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The alert applies to…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • Cardinal Health issues updated instructions for Presource kits containing recalled BD Alaris infusion sets
    The FDA CDRH issued an Early Alert to inform the public of a potentially high‑risk device issue involving Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets linked to a re…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 1d agoCRLNegative↗ source
  • AstraZeneca partners with Oracle to boost clinical trial patient recruitment using AI
    AstraZeneca announced a collaboration with data-technology firm Oracle to apply artificial-intelligence tools to clinical-trial recruitment. The non-binding agreement will let the partners explore…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA issues final guidance on developing and labeling prescription drug apps
    The FDA released its final guidance on Tuesday, outlining how drug sponsors should create, distribute, and label software applications that are used together with prescription medicines. The guida…
    raps · 1d agoRegulatoryPositive↗ source
  • Lycia Therapeutics targets $228M IPO to fund food allergy protein degrader programs
    Lycia Therapeutics announced plans for an initial public offering expected to raise about $228 million. The proceeds are intended to support its pipeline of protein degrader therapeutics targeting…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • FDA and UK regulators discuss new frameworks for generative AI oversight
    At the MedTech Conference in Boston, officials from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency met to talk about how to regulate generati…
    raps · 1d agoRegulatoryNeutral↗ source
  • SCRS unveils Eagle Insights Dashboard to benchmark clinical trial site performance
    The Society for Clinical Research Sites introduced a new data intelligence platform called the Eagle Insights Dashboard. The tool provides sponsors and contract research organizations with a compos…
    Fierce Biotech · 1d agoPositive↗ source
  • Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
    Cardinal Health Presource Kits containing recalled BD Alaris Pump Infusion Sets should be corrected prior to continued use.
    fda medwatch · 1d ago↗ source
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • Roche signs $15 billion ADC partnership with China's Hansoh Pharma
    Roche has re-entered a partnership with China's Hansoh Pharmaceutical, signing a $15 billion biobucks agreement. The deal covers a broad portfolio of antibody-drug conjugate programs, including tw…
    Fierce Biotech · 2d agoDealPositive↗ source