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  • GSK and Ionis receive FDA nod for Hibsago, a potential functional cure for chronic hepatitis B
    The U.S. Food and Drug Administration has cleared Hibsago, a collaborative product of GSK and Ionis, as the first therapy of its kind aimed at chronic hepatitis B. The medicine is to be added to s…
    BioPharma Dive · 2h agoApprovalPositive↗ source
  • 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 · 4h agoApprovalPositive↗ source
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  • US patients skip half of new high-cost drugs as prices surge past $250K
    A new report from the Institute for Clinical and Economic Review and West Health finds that only about one-third of patients prescribed newly launched medicines actually fill them within 30 days, w…
    BioSpace · 5h agoNegative↗ 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 · 9h agoPositive readoutPositive↗ source
  • Roivant's brepocitinib shows strong Phase 3 results, paving way for uveitis indication
    Roivant subsidiary Priovant Therapeutics announced positive Phase 3 data for its anti‑inflammatory drug brepocitinib in patients with non‑infectious uveitis, an eye disease that can cause blindness…
    BioPharma Dive · 3h agoRegulatoryPositive↗ source
  • FDA approves GSK‑Ionis hepatitis B functional cure, Hibsago, targeting undetectable virus after six months
    The FDA has approved bepirovirsen, an antisense oligonucleotide from GSK and Ionis, for chronic hepatitis B infection. It will be sold under the brand name Hibsago. The therapy is described as a f…
    BioSpace · 5h agoApprovalPositive↗ source
  • US biotech M&A surges as Chinese licensing deals dominate 2026 market
    Locust Walk reports that China now accounts for 58% of global licensing deal value in 2026, while the United States share has dropped to 26%. Despite the licensing shift, US biotech companies are…
    BioSpace · 14h agoDealPositive↗ source
  • Disc Medicine’s Phase 3 data revives rejected rare‑disease drug as China tightens biotech ownership rules
    Disc Medicine announced that its Phase 3 trial of a previously rejected rare‑disease therapy showed positive results, effectively rescuing the program and positioning it for another submission to t…
    BioSpace · 5h agoPositive readoutPositive↗ source
  • Novo reports 25% average weight loss in women using CagriSema, with greatest loss in premenopausal patients
    Novo's next-generation GLP-1 drug CagriSema showed substantial weight loss in women enrolled in the Phase 3 REDEFINE 1 trial. Women in the study lost about 25% of their body weight after 68 weeks,…
    BioSpace · 6h agoPositive readoutPositive↗ 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 · 10h 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 · 16h agoDealPositive↗ source
  • FDA cites Baxter’s inadequate oversight after repeated GMP violations at multiple plants
    The U.S. Food and Drug Administration has issued a warning letter to Baxter International, saying the company's leadership has failed to provide adequate oversight of its drug manufacturing operati…
    BioSpace · 1h agoRegulatoryNegative↗ source
  • Arcus kidney cancer drug shows stronger potency than Merck's Welireg, boosting shares
    Arcus Biosciences reported follow‑up data from its late‑stage kidney cancer trial that suggest its experimental therapy, casdatifan, may be more potent than Merck's approved drug Welireg. Analysts…
    BioPharma Dive · 4h agoPositive readoutPositive↗ 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 · 5h 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 · 6h 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 · 6h 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 · 9h 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 · 10h agoPositive↗ source
  • Crossover fundraisings may hit $4.2 billion in 2026, with 2025 rounds still leading historic totals
    Crossover rounds are viewed as a bridge to public markets, with Jim Healy of Sofinnova Investments saying a large raise signals a company has reached a level of maturity and broader institutional i…
    BioSpace · 14h agoDealNeutral↗ 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 · 15h 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 · 16h 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 · 49m agoNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 7h agoNeutral↗ 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 · 9h 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 · 10h agoNegative↗ source