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1,797 stories matching this filter · ← front page

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  • FDA grants rapid approval to Revolution Medicines' pancreatic cancer drug Rasonque
    FDA approved Revolution Medicines' pancreatic cancer therapy Rasonque, just over a month after submission using a priority review voucher. The drug, formerly known as daraxonrasib, is for patients…
    BioPharma Dive · 3h agoApprovalPositive↗ source
  • FDA grants early approval to RevMed's pancreatic cancer drug Rasonque
    FDA granted early approval to Revolution Medicines' daraxonrasib, now named Rasonque, for pancreatic adenocarcinoma, arriving 6.5 months before the FDA deadline. The oral RAS inhibitor demonstrate…
    BioSpace · 5h agoApprovalPositive↗ source
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  • Summit Therapeutics and Akeso report Phase 3 survival benefit for ivonescimab in Chinese biliary tract cancer
    Summit Therapeutics and its Chinese partner Akeso said their bispecific antibody ivonescimab combined with chemotherapy improved overall survival for patients with first-line biliary tract cancer i…
    BioSpace · 7h agoPositive readoutPositive↗ source
  • Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancer
    The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gas…
    BioSpace · 9h agoApprovalPositive↗ source
  • Biohaven sells rights to its lead epilepsy drug opakalim to SK Biopharma for up to $795 million
    Biohaven announced it will transfer the rights to its most advanced experimental therapy for focal epilepsy, known as opakalim, to South Korean company SK Biopharma. The agreement could bring as m…
    BioPharma Dive · 5h agoDealNeutral↗ source
  • FDA approves Revolution Medicines' daraxonrasib for second-line pancreatic cancer
    The U.S. Food and Drug Administration announced approval of Revolution Medicines' drug daraxonrasib for patients with pancreatic cancer who have already received prior therapy. The approval marks…
    Endpoints · 5h agoApprovalPositive↗ source
  • Spyre shares plunge as rheumatoid arthritis trial of SPY072 falls short of internal target
    Spyre Therapeutics reported that its antibody SPY072 did not meet the company’s internal criteria in a mid‑stage rheumatoid arthritis trial, despite showing some activity. The placebo‑controlled s…
    BioPharma Dive · 4h agoNegative readoutNegative↗ source
  • Biohaven secures up to $795 million partnership with SK Biopharma for global epilepsy drug rights
    Biohaven announced a commercial partnership for its late-stage epilepsy program. South Korea-based SK Biopharma has agreed to pay up to $795 million for worldwide rights to the company's Kv7 ion ch…
    Endpoints · 3h agoDealPositive↗ source
  • Vitruvias Therapeutics shuts down after recalling potentially superpotent thyroid tablets
    Vitruvias Therapeutics announced it is ceasing operations and has voluntarily recalled a batch of its generic thyroid tablets because the product may be superpotent. The recall covers 3,655 units…
    BioSpace · 2h agoCRLNegative↗ source
  • MassBio CEO warns 2025 may be biotech's toughest year amid China and NIH challenges
    Massachusetts is widely regarded as the epicenter of biotech because of its world‑class research institutions and vibrant startup ecosystem. MassBio CEO Kendalle Burlin O’Connell said 2025 will pr…
    Endpoints · 3h agoNegative↗ source
  • Haisco licenses inflammatory disease candidate to US startup Sentivera; ViiV's HIV drug cleared for newborns
    Haisco Pharmaceutical announced that it has granted a license to US biotech Sentivera for the ex‑China rights to an unnamed inflammatory‑disease candidate. The agreement gives Sentivera the ability…
    Endpoints · 5h agoDealNeutral↗ source
  • Aurora Therapeutics halts lead CRISPR program and cuts staff
    Aurora Therapeutics, founded as the first company dedicated to developing custom CRISPR-based gene-editing medicines, announced a major restructuring. The firm said it is laying off several employ…
    Endpoints · 6h agoLayoffsNegative↗ source
  • Study finds Lilly's obesity drug Zepbound may lower hospital and ER costs for older adults
    A real‑world analysis examined older patients with obesity or excess weight who were either treated with Eli Lilly’s drug Zepbound or not. The researchers tracked healthcare utilization over time t…
    BioPharma Dive · 6h agoPositive readoutPositive↗ source
  • Akeso and Summit report ivonescimab meets primary endpoint in China Phase 3 biliary tract cancer trial
    Akeso Therapeutics and partner Summit Therapeutics announced that their bispecific antibody ivonescimab achieved the primary efficacy endpoint in a Phase 3 study conducted exclusively in China. Th…
    Endpoints · 9h agoPositive readoutPositive↗ source
  • Faro AI secures $37M Series B to accelerate clinical trials with artificial intelligence
    Faro AI, a San Diego‑based startup, announced a $37 million Series B financing round aimed at expanding its artificial‑intelligence platform. The new funding will be directed toward developing too…
    Endpoints · 9h agoDealPositive↗ source
  • FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy review
    The FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
    BioSpace · 10h agoRegulatoryNeutral↗ source
  • CDMO hiring struggles as demand for specialized talent outpaces supply
    Contract development and manufacturing organizations are finding it harder to fill positions, according to a search expert who tracks life-science talent. The surge in outsourcing has created a gap…
    BioSpace · 13h agoNeutral↗ source
  • Spyre Therapeutics deprioritizes anti-TL1A rheumatoid arthritis candidate after modest Phase 2 results
    Spyre Therapeutics said on Tuesday it will shift resources away from its anti-TL1A antibody that was being developed for rheumatoid arthritis. The decision follows the Phase 2 study, which showed…
    Endpoints · 9h agoNegative readoutNegative↗ source
  • Inside the Gulf biotech deal model, ahead of RGMBS 2026 in Riyadh
    Sovereign capital, guaranteed offtake, and localization mandates are reshaping how biotech deals get structured in the Gulf, ahead of the Riyadh Global Medical Biotechnology Summit (RGMBS) 2026, 14…
    BioSpace · 15h agoDealNeutral↗ 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 · 9h agoNeutral↗ source
  • Cellares defends its cell therapy platform after Bristol Myers ends partnership
    Cellares, a cell therapy manufacturing startup, responded to criticism from Bristol Myers Squibb after the drugmaker terminated their agreement. Bristol Myers withdrew, saying Cellares' commercial…
    Endpoints · 3h agoNegative↗ source
  • FDA reportedly weighing two new deputy commissioner roles, one for health AI and one for drugs
    The Food and Drug Administration is said to be considering the creation of two additional deputy commissioner positions. The proposal is being reported by media outlets but has not been confirmed b…
    BioSpace · 9h agoRegulatoryNeutral↗ source
  • BMS ends Cellares pact over cell therapy production problems, triggering layoffs
    Setbacks to efforts to use Cellares’ automated platform to make an approved CAR-T cell therapy led BMS to terminate its partnership with the manufacturing specialist.
    BioSpace · 8h ago↗ source
  • Biohaven could get up to $795M in epilepsy alliance with SK Bio
    At the center of Biohaven’s agreement with SK Biopharmaceutical is the ion channel platform and the lead epilepsy candidate opakalim, for which Phase 2/3 data are expected later this year.
    BioSpace · 8h ago↗ source
  • FDA greenlights Revolution Medicines' pancreatic cancer gamechanger
    Following dynamite data that earned a standing ovation at the American Society of Clinical Oncology meeting in May, Revolution Medicines’ Ras inhibitor daraxonrasib has been approved by the FDA for…
    Fierce Biotech · 9h ago↗ source