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  • GSK receives FDA approval for hepatitis B therapy that expands functional cure rates
    GSK announced that the U.S. Food and Drug Administration has granted approval for its hepatitis B drug. The agency said the treatment can achieve functional cures in a larger proportion of patient…
    STAT · 20d agoApprovalPositive↗ source
  • 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 · 20d agoPositive readoutPositive↗ source
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  • Merck and Moderna release early phase 3 melanoma vaccine data showing primary endpoint success but weaker secondary results
    Merck and Moderna disclosed phase 3 data for their melanoma vaccine INTerpath-001 ahead of schedule after an embargo breach. The trial met its primary endpoint of recurrence‑free survival, with re…
    Fierce Biotech · 20d agoPositive readoutNeutral↗ source
  • German biotech Immatics eyes pivotal Phase 3 readout after promising uveal melanoma cell therapy results
    Immatics, a German biotech founded 26 years ago, is focusing on cancer immunotherapy. Its lead candidate is an experimental cell therapy targeting uveal melanoma. Early Phase 1 data in 16 patients…
    STAT · 20d agoPositive↗ 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 · 20d agoDealPositive↗ source
  • Wedgewood Pharmacy recalls multiple compounded veterinary meds over potency testing inconsistencies
    Wedgewood Pharmacy LLC announced a recall of certain compounded veterinary medications that are still within their expiration dates. The recall is due to inconsistencies in the reliability of anal…
    fda recalls · 19d agoCRLNegative↗ source
  • Mark Cuban’s Cost Plus Drugs plans to enter custom rare-disease drug market
    Mark Cuban says his company Cost Plus Drugs will expand beyond generic medicines into the custom‑made rare disease space. The firm, which currently buys generic drugs and sells them directly to con…
    STAT · 20d agoDealPositive↗ source
  • Roivant reports Lisraya beats placebo in Phase 3 trials for non-infectious uveitis
    Roivant and its spinout Priovant announced that Lisraya, an immune-modifying oral drug, showed statistically significant benefit over placebo in two Phase 3 trials for non-infectious uveitis. The…
    STAT · 20d agoPositive readoutPositive↗ source
  • Nigeria confirms travel-linked Ebola case tied to DRC outbreak
    Nigeria's Ministry of Health announced a confirmed Ebola infection in a traveler, marking the country's first case linked to the ongoing outbreak in the Democratic Republic of the Congo. The patie…
    STAT · 20d agoNeutral↗ source
  • 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 · 20d agoDealPositive↗ source
  • Mark Cuban's Cost Plus Drugs targets rare disease market with custom n-of-1 therapies
    Mark Cuban's Cost Plus Drugs, known for low-cost generics, is expanding into rare disease treatments. The company has dedicated part of its new manufacturing plant to producing custom "n-of-1" the…
    STAT · 20d agoPositive↗ 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 · 20d 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 · 20d agoDealNeutral↗ source
  • Isomorphic Labs' soaring valuation sparks debate over AI’s impact on drug development and healthcare costs
    Isomorphic Labs, a biotech spin‑out that applies generative AI to design new medicines, recently secured a multi‑billion‑dollar valuation that has captured industry attention. The lofty figure is…
    STAT · 19d agoNeutral↗ source
  • ADA chief scientific officer Rita Kalyani departs amid ongoing review of New Orleans incident
    The American Diabetes Association announced Tuesday that its chief scientific and medical officer, Dr. Rita Kalyani, is no longer in her role, effective immediately. The move comes as the ADA cont…
    STAT · 19d agoNegative↗ 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 · 20d agoRegulatoryNeutral↗ source
  • Rising US measles cases highlight need for door-to-door public health outreach
    The United States is experiencing its largest measles outbreak in more than 30 years, with over 4,400 confirmed cases and more than a thousand people sickened so far this year. Pennsylvania alone h…
    STAT · 20d agoNegative↗ source
  • Experts suggest emphasizing measles survival rates to boost vaccine trust
    The United States has reported more than 4,400 measles cases this year, roughly twice the number recorded in 2025. At the same time, vaccination rates have fallen in over 1,600 counties between 201…
    STAT · 20d agoNeutral↗ source
  • NIH Scales Back Replication Initiative, Critics Warn It Undermines Scientific Rigor
    NIH originally announced a push to make replication a core part of biomedical research, including an $850,000 Replication Prize launched in March 2025. Health secretary Robert F. Kennedy Jr. sugge…
    STAT · 20d agoNegative↗ source
  • CMS expands fraud crackdown to New York adult day-care program, calls it a "plague to the state"
    CMS announced it will use its new authority to remove providers from federal health programs, focusing on adult day-care centers in New York City. The agency says the Social Adult Day Care (SADC)…
    STAT · 19d agoRegulatoryNegative↗ 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 · 21d agoPositive readoutPositive↗ source
  • New drug launch prices climb 35% to $257,000 median, with a quarter exceeding $500,000
    A recent analysis of 202 newly launched medicines shows the median net price jumped 35% last year, reaching $257,000 compared with $173,000 in 2022. The study adjusted prices for inflation and typi…
    STAT · 21d agoRegulatoryNegative↗ source
  • Massachusetts moves to revoke all RegalCare nursing home licenses after Boston Globe investigation
    Massachusetts regulators announced on Oct 13 that they will revoke every nursing home license held by RegalCare, a New Jersey‑based operator that acquired a dozen facilities in the state after the…
    STAT · 20d agoRegulatoryNegative↗ source
  • Roche signs major partnership with China's Hansoh to co-develop antibody-drug conjugates
    Roche announced a deal with China's Hansoh Pharmaceutical Group to develop a portfolio of antibody-drug conjugates (ADCs). The agreement is described as massive, indicating a significant collabora…
    STAT · 21d agoDealPositive↗ source
  • Median net price of new drugs jumps 35% from 2022 to 2025, reaching $257,000
    The Institute for analysis reports that the median net price for 202 newly launched medicines rose 35% between 2022 and 2025 after adjusting for inflation and manufacturer discounts. The median pr…
    STAT · 21d agoNeutral↗ source