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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 · 6h agoApprovalPositive↗ source
  • 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 · 8h agoNegative↗ source
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  • GSK and Ionis receive FDA nod for hepatitis B therapy promising functional cure
    GSK and Ionis announced that the U.S. Food and Drug Administration has approved their hepatitis B drug bepirovirsen, now marketed as Hibsago. The therapy is intended for chronic hepatitis B patien…
    Endpoints · 11h 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 · 12h 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 · 6h 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 · 8h 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 · 18h 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 · 8h 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 · 10h 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 · 20h agoDealPositive↗ source
  • Treasury to tighten scrutiny of China biotech acquisitions under upcoming rules
    Treasury Secretary Scott Bessent announced on Sept 9 2026 that the Treasury Department will issue new guidance that makes it harder for U.S. pharma companies to complete biotech deals in China. Th…
    Endpoints · 3h agoRegulatoryNegative↗ 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 · 5h agoRegulatoryNegative↗ source
  • CSL appoints former ViiV and GSK veteran Deborah Waterhouse as new CEO
    CSL announced that Deborah Waterhouse will become its chief executive. The appointment follows her departure from GSK, where she spent three decades. Waterhouse most recently led ViiV Healthcare,…
    Endpoints · 7h agoPositive↗ source
  • Alcon buys Neurotech for $550 million upfront
    Alcon, the Swiss eye‑care company, announced it has completed the acquisition of Neurotech Pharmaceuticals. The transaction includes an upfront cash payment of $550 million, with the possibility o…
    Endpoints · 7h agoDealNeutral↗ source
  • Roivant's autoimmune drug brepocitinib succeeds in two pivotal trials, paving way for 2027 filing
    Roivant Sciences said its autoimmune drug brepocitinib met primary goals in two pivotal studies. The trials, which evaluated the drug in separate autoimmune indications, showed statistically signi…
    Endpoints · 7h agoPositive readoutPositive↗ 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 · 7h agoPositive readoutPositive↗ 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 · 12h agoDealPositive↗ source
  • Lilly advances retatrutide toward sleep-apnea market
    Eli Lilly is moving its triple-agonist drug retatrutide closer to a potential launch for sleep-apnea. The company, which expects to introduce the drug for obesity next year, is now gathering data i…
    Endpoints · 16h 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 · 18h 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 · 18h 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 · 19h agoDealNeutral↗ source
  • Samsung Biologics union vows appeal after court blocks planned strike
    A Seoul court granted Samsung Biologics an order that prevents its labor union from holding a strike that had been scheduled for the company's bio-manufacturing campus. The union, representing con…
    Endpoints · 5h agoNegative↗ source
  • Endpoints AI Day highlights agents, AI slop and biosecurity gaps in pharma
    Endpoints News held its third AI Day, an event dedicated to exploring how artificial intelligence can be applied across drug discovery and development. Speakers, including Nathan Frey of Anthropic…
    Endpoints · 6h 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 · 10h 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 · 12h agoRegulatoryNeutral↗ source