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1,984 stories matching this filter · ← front page

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  • FDA advisory panel finds Grail's Galleri multicancer blood test benefits outweigh risks
    A Food and Drug Administration advisory panel voted 7-2, with one abstention, to conclude that the probable benefits of Grail's Galleri multicancer blood test outweigh its risks. The panel unanimou…
    BioPharma Dive · 26d agoRegulatoryPositive↗ source
  • Eli Lilly partners with China’s InnoCare on drug development deal worth up to $3.35 billion
    Eli Lilly has signed a partnership agreement with Beijing-based InnoCare to co-develop new medicines. InnoCare will apply its internal drug discovery platform while Lilly will contribute its devel…
    Endpoints · 27d agoDealPositive↗ source
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  • Merck's remigromig meets visual acuity goal in diabetic macular edema trial, safety signals noted
    Merck announced that its experimental eye drug remigromig achieved non‑inferiority to Roche’s Lucentis in a late‑stage trial for diabetic macular edema. The trial, called Brunello, measured visual…
    BioPharma Dive · 27d agoPositive readoutNeutral↗ source
  • Roche signs discovery partnerships with Atavistik Bio and Earendil Labs
    Roche announced new collaborations with the drug discovery companies Atavistik Bio and Earendil Labs to develop early-stage candidates. The agreements continue a recent wave of dealmaking by the S…
    Endpoints · 27d agoDealNeutral↗ source
  • Acadia’s Alzheimer’s psychosis drug misses Phase 2 goals, but moves to revised Phase 3
    Acadia Pharmaceuticals announced that its experimental treatment for psychosis linked to Alzheimer’s disease failed to meet the primary endpoints in a Phase 2 trial. The company said the data stil…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Eli Lilly inks $3.35 B China partnership as Immunovant halts lupus drug trial
    Eli Lilly announced a new alliance with Beijing‑based InnoCare Pharma that could be worth up to $3.35 billion. The deal includes an upfront payment of $100 million and up to five target programs fo…
    BioPharma Dive · 27d agoDealNeutral↗ source
  • Merck's $1.3B EyeBio investment yields first ophthalmology success
    Merck's strategic move to re-enter ophthalmology has begun to show results after its 2024 acquisition of EyeBio. The company committed $1.3 billion upfront for EyeBio, aiming to broaden its pipeli…
    Endpoints · 27d agoDealPositive↗ source
  • Kyverna reports positive one-year CAR-T results for rare stiff person syndrome, supporting FDA filing
    Kyverna Therapeutics announced that its CAR-T therapy for stiff person syndrome showed positive results after one year of treatment. The trial involved patients with the rare autoimmune disorder,…
    Endpoints · 27d agoPositive readoutPositive↗ source
  • Elevar Therapeutics receives FDA approval for Lyrfigtu as second-line treatment for bile duct cancer
    The U.S. Food and Drug Administration has approved Elevar Therapeutics' drug Lyrfigtu as a second‑line option for patients with bile duct cancer who meet specific criteria. Bile duct cancer is dia…
    Endpoints · 27d agoApprovalPositive↗ source
  • AI doomsday warnings may curb health-tech innovation, Epic cautions
    Recent commentary warns that sensational AI doomsday predictions could slow the pace of health‑technology innovation. Epic, the large electronic health‑record company that provides AI tools to hos…
    Endpoints · 27d agoNegative↗ source
  • Sarepta Therapeutics agrees to pay $39 million to settle gene therapy dispute with Regenxbio
    Sarepta Therapeutics has agreed to resolve a dispute with Regenxbio by paying $39 million. The payment settles claims related to gene therapy technology that both companies have been developing.…
    Endpoints · 27d agoDealNeutral↗ source
  • Heidi Overton, Trump’s FDA commissioner nominee, to face Senate confirmation hearing
    Heidi Overton has been nominated by President Donald Trump to serve as the next commissioner of the U.S. Food and Drug Administration. She is scheduled to appear before the Senate Health, Educatio…
    Endpoints · 27d agoRegulatoryNeutral↗ source
  • FDA nominee Overton parries vaccine questions at Senate hearing
    Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.
    BioPharma Dive · 26d ago↗ source
  • FDA approves Eli Lilly's once-weekly insulin pen, setting up rivalry with Novo
    Eli Lilly’s once-weekly basal insulin shot Onswik has been approved by the FDA for patients with type 2 diabetes. Lilly has touted Onswik as a longer-acting alternative to daily basal insulin injec…
    Endpoints · 27d ago↗ source
  • Roche and Ionis report positive Phase 3 interim results for IgA nephropathy drug sefaxersen
    Roche and Ionis announced that their experimental RNA therapy sefaxersen met its primary endpoint in an interim analysis of a Phase 3 trial for IgA nephropathy. The trial showed statistically sign…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • European pharma CEOs warn of biotech decline as R&D share drops to 31% and call for faster trials and stronger IP protection
    Nine leading European pharma board chairs issued an open letter warning that Europe is losing its biotech edge. They note that Europe's share of global pharma R&D fell from 43% in 1990 to 31% toda…
    BioPharma Dive · 28d agoNegative↗ source
  • FDA panel questions effectiveness of Grail's early-cancer detection test
    FDA's Molecular and Clinical Genetics Panel and agency officials raised concerns about Grail's next-generation sequencing test designed to detect multiple cancers early in adults over 50. The advi…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • World's first personalized gene-editing therapy costs $1.65 million per patient, project director says
    At a rare disease conference in Oxford, Fyodor Urnov disclosed that the world's first therapy designed to correct an individual’s unique genetic mutation cost $1.65 million to produce. The treatme…
    Endpoints · 28d agoNeutral↗ source
  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 28d agoDealPositive↗ source
  • Former Changsheng biotech chair sentenced to life in prison over Chinese rabies vaccine scandal
    Chinese authorities sentenced Gao Junfang, the former chairwoman of Changsheng Biotechnology, to life imprisonment after a court found her guilty of wrongdoing in a rabies vaccine scandal. The cas…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • Enveda secures $311 million in third consecutive megaround to advance discovery and weight-maintenance programs
    Enveda, a biotech startup operating out of Colorado and India, announced a new financing round on September 23, 2026. The company raised $311 million, marking its third large-scale funding round i…
    Endpoints · 28d agoDealPositive↗ source
  • AI startup Basecamp Research secures $140 million Series C funding and outlines six-program AI pipeline
    Basecamp Research, an AI-driven biotech founded in 2019, announced a $140 million Series C financing round. The company said the new capital will support its ambitious six-program pipeline that ap…
    Endpoints · 28d agoDealPositive↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 28d agoPositive readoutPositive↗ source
  • Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trial
    Roivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…
    Endpoints · 28d agoNegative readoutNegative↗ source
  • Family’s struggle to receive cystic fibrosis medication highlights care gaps
    Stephanie Marquart in Knoxville, Tennessee, waited anxiously for a delivery to her home, refreshing the tracking page repeatedly as the package made its way to her doorstep. The episode, described…
    Endpoints · 28d agoNegative↗ source