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  • Roche talks up Phase 3 success rate as it unveils pipeline cuts
    Where other European pharmas — notably Novartis, Novo and AstraZeneca — have suffered huge late-stage clinical failures this summer, Roche is feeling rather smug. CEO Thomas Schinecker said ...
    Endpoints · 1h ago↗ source
  • 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 · 1d agoApprovalPositive↗ source
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Rezera files for IPO to fund NLRP3 peripheral artery disease program
Rezera, which rebranded from NodThera earlier this year, has entered the queue for an initial public offering. The filing, submitted on Wednesday, is intended to raise capital to support the compa…
Endpoints · 11h 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 · 16h 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 · 20h 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 · 20h 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 · 20h agoPositive readoutPositive↗ 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 · 1d agoPositive↗ source
  • China biotech RiboX reports first human data for circular RNA therapies
    China biotech company RiboX has disclosed its initial human data on circular RNA therapeutics, marking the first clinical readout for this emerging platform. The study represents a milestone for t…
    Endpoints · 12h agoNeutral↗ 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 · 18h agoNegative↗ source
  • FDA device officials prioritize hiring after layoffs, express optimism for upcoming MDUFA VI agreement
    Top officials from the FDA's Center for Devices and Radiological Health spoke at a town‑hall session during The MedTech Conference. They said the agency is concentrating on rebuilding staff after a…
    raps · 1d agoRegulatoryPositive↗ 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 · 20h agoNeutral↗ source
  • Pharma companies push FDA for risk-based flexibility in container-closure testing guidance
    Major pharma firms have written to the FDA urging a shift in its current guidance on testing container-closure systems for drug and biologic products. They argue that a risk-based, flexible approa…
    raps · 1d 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 · 1d agoApprovalPositive↗ source
  • Biopharma Sentiment Index climbs to upbeat 105 in Q3 2026, marking strongest optimism in years
    Endpoints Signal released its Q3 2026 Biopharma Sentiment Index, showing a dramatic lift in industry mood. The survey indicates the sector is finally in a positive territory after a four-year downt…
    Endpoints · 1d agoPositive↗ 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 · 2d agoApprovalPositive↗ source
  • ICER report finds median launch drug prices jumped 24% between 2022 and 2025
    The Institute for Clinical and Economic Review released a new analysis showing that the median list price of newly launched drugs increased by 24% from 2022 to 2025. The report also notes that net…
    Endpoints · 1d agoNegative↗ 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
  • Pfizer halts Phase 2 trial of PF-06835375 in primary immune thrombocytopenia
    Pfizer announced that it is stopping its Phase 2 study of the experimental program PF-06835375, which was being evaluated in patients with primary immune thrombocytopenia, a rare autoimmune blood d…
    Endpoints · 1d agoNegative readoutNegative↗ 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 reports Phase 2 success for J&J-licensed bipolar mania drug
    Rapport Therapeutics announced that its oral investigational drug, which modulates AMPA receptors, has successfully completed a Phase 2 trial in patients with bipolar mania. The study met its prim…
    Endpoints · 2d agoPositive readoutPositive↗ 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 · 2d 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 · 2d 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 · 2d agoCRLNegative↗ 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 · 2d agoRegulatoryPositive↗ source