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  • Biotech firm Biogen secures Chinese approval for felzartamab in second-line multiple myeloma
    Biogen announced that its monoclonal antibody felzartamab has received regulatory clearance in China for use in patients with multiple myeloma who have already received first-line therapy. The app…
    Endpoints · 49m agoApprovalPositive↗ source
  • Capricor to submit additional data to FDA after negative advisory committee vote on Duchenne therapy
    Capricor Therapeutics announced it will request the FDA to review new data and analyses for its experimental treatment for Duchenne muscular dystrophy. The move follows a recent negative vote from…
    Endpoints · 2h agoRegulatoryNegative↗ source
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  • Abcuro raises $66 million to launch Phase 3 trial in muscle-weakening disease after earlier setback
    Abcuro announced it has secured $66 million in financing to support a Phase 3 clinical study targeting a muscle-weakening condition. The funding comes after the company previously reported that it…
    Endpoints · 2h agoDealNeutral↗ source
  • Redx Pharma pursues new reverse merger with Skye after 2023 setback
    Redx Pharma, a UK biotech focused on ROCK inhibitor therapies for fibrosis, is seeking a reverse merger with Skye to obtain a Nasdaq listing. The company previously attempted a similar transaction…
    Endpoints · 2h agoDealNeutral↗ source
  • Bicara appoints President Ryan Cohlhepp as CEO effective Jan. 1, while J&J veteran John Reed joins Madrigal board
    Bicara Therapeutics announced a leadership transition, naming its current President and COO Ryan Cohlhepp as the new chief executive officer effective Jan. 1. Cohlhepp will take over the role as t…
    Endpoints · 7h agoNeutral↗ source
  • MapLight Therapeutics pauses early‑stage programs to focus on lead schizophrenia and Alzheimer’s psychosis candidate
    MapLight Therapeutics announced it is pausing its preclinical and discovery activities. The company said it will redirect resources toward advancing its lead candidate, ML-007C-MA, which is being d…
    Endpoints · 3h agoNeutral↗ source
  • ICER says AstraZeneca’s new blood pressure med isn’t cost-effective
    The drug price watchdog ICER issued a report Thursday concluding that the benefits of AstraZeneca’s new blood pressure pill Baxfendy don’t justify its $10,950 per year price tag. Baxfendy is foreca…
    Endpoints · 2h ago↗ source
  • FDA grants accelerated approval to Bristol Myers' iberdomide for relapsed or refractory multiple myeloma
    The U.S. Food and Drug Administration has issued an accelerated approval for iberdomide, a small-molecule therapy developed by Bristol Myers Squibb. The approval targets patients with multiple mye…
    Endpoints · 20h agoApprovalPositive↗ source
  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • European regulators withdraw Amgen's Tavneos over questionable data
    European regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading. The authorities said the data s…
    Endpoints · 23h agoRegulatoryNegative↗ source
  • FDA's PDUFA VIII adds 'America First' incentives and speeds up drug reviews
    The Food and Drug Administration announced the next five‑year reauthorization of the Prescription Drug User Fee Act, known as PDUFA VIII. The agency said the new framework will introduce several po…
    Endpoints · 1d agoRegulatoryPositive↗ source
  • Karyopharm faces default risk with only a month left to rescue cancer expansion
    Karyopharm Therapeutics, a commercial-stage cancer drugmaker, is confronting severe financial strain as its market capitalization is roughly one‑third of the revenue it expects to generate in 2026.…
    Endpoints · 1d agoNegative↗ source
  • Khartis Therapeutics secures $50 million Series B funding from Forge Life Science Partners, Longwood Fund and Lilly Asia Ventures
    San Diego-based Khartis Therapeutics announced a $50 million Series B financing round. The round was led by Forge Life Science Partners and included participation from Longwood Fund, Lilly Asia Ve…
    Endpoints · 1d agoDealPositive↗ source
  • PTC Therapeutics and Eli Lilly to acquire parts of bankrupt Sangamo for up to $264 million
    The gene-editing company Sangamo Therapeutics has filed for bankruptcy, placing its assets up for sale. An auction process has identified two bidders: PTC Therapeutics and Eli Lilly, which togethe…
    Endpoints · 1d agoDealNeutral↗ source
  • Aligned Marketplace secures $20 million to link self-insured employers with primary-care clinics
    Aligned Marketplace is a health‑tech startup that matches self‑insured employers with primary‑care clinics, helping companies provide direct access to medical services for their workers. The compa…
    Endpoints · 1d agoDealPositive↗ source
  • Epilepsy drug from Ovid and Takeda receives fresh start under Perceptive-backed venture
    After about 26 months since two Phase 3 trials failed, the epilepsy treatment candidate originally developed by Ovid Therapeutics and Takeda has been removed from their pipelines. Investment firm…
    Endpoints · 23h agoDealNeutral↗ source
  • FDA grants emergency use authorization for Simparica TRIO to treat New World screwworm in dogs and puppies
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Simparica TRIO, a chewable tablet containing sarolaner, moxidectin and pyrantel, to treat New World screwworm infesta…
    fda press · 1d agoRegulatoryPositive↗ source
  • Experts warn of deaths linked to Neurocrine's Vykat XR for Prader-Willi syndrome
    A coalition of specialists in Prader-Willi syndrome has raised serious concerns about the safety profile of Neurocrine Biosciences' drug Vykat XR. The experts point to a series of adverse events,…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • AbCellera, Silence and InduPro secure major funding rounds as AbCellera completes $200M share sale
    Vancouver based biotech AbCellera announced a $200 million share offering after meeting its efficacy targets in a Phase 2 hot flashes trial. The capital raise follows the company achieving its pred…
    Endpoints · 2d agoDealPositive↗ source
  • FDA outlines new onshoring incentives and meeting types for generic drug applicants under GDUFA IV
    The FDA released its GDUFA IV commitments, indicating that review timelines for generic drug submissions will remain largely consistent through 2032, mirroring the schedule of the previous five yea…
    Endpoints · 2d agoRegulatoryNeutral↗ source
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • Boulevard Bio raises $65M to expand immunology pipeline, eyes Vera's IgAN candidate
    Boulevard Bio announced it has secured $65 million in financing to broaden its immunology portfolio. The new capital will support the development of two immune‑resetting drugs the company discovere…
    Endpoints · 2d agoDealPositive↗ source
  • Eli Lilly sues six U.S. firms over alleged black-market sales of investigational drug retatrutide
    Eli Lilly has filed lawsuits against six U.S. companies it says are selling its investigational diabetes and weight-loss drug retatrutide. The companies are accused of operating a black-market for…
    Endpoints · 2d agoNegative↗ source
  • Vaccine makers say splitting MMR vaccine is impractical despite presidential directive
    Vaccine manufacturers responded to a recent order from President Donald Trump to separate the combined measles, mumps and rubella (MMR) vaccine, noting that while the concept is theoretically possi…
    Endpoints · 1d agoNeutral↗ source
  • Endpoints News recaps Boston China biotech debate on industry’s China outlook
    Last week Endpoints News hosted a live debate in Boston that brought together leading voices in biopharma to discuss China’s growing role in the industry. The panel featured executives and investo…
    Endpoints · 2d agoNeutral↗ source