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953 stories matching this filter · ← front page

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  • 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 · 2h agoApprovalPositive↗ source
  • 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 · 4h agoPositive readoutPositive↗ source
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73
fda recalls54
fda medwatch47
fda press30
Pulmonology940
Psychiatry & CNS757
Ophthalmology455
Pain424
Endocrinology & Metabolism402
Infectious Disease380
  • 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 · 6h 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 · 2h agoDealNeutral↗ 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 · 1h agoNegative readoutNegative↗ 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 · 4h agoPositive readoutPositive↗ 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 · 7h 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 · 11h agoNeutral↗ 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 · 13h 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 · 6h agoNeutral↗ 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 · 6h agoRegulatoryNeutral↗ source
  • Revival Animal Health, LLC Voluntarily Recalls Feline Milk Replacers Due to Inconsistent Levels of Vitamins and Trace Minerals
    Revival Animal Health of Orange City, IA is recalling Breeder’s Edge® and Shelter’s Choice® Feline Milk Replacers due to low, levels of potassium, copper, folic acid, choline and/or pyridoxine (vit…
    fda recalls · 4h ago↗ 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 · 5h 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 · 5h 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 · 6h ago↗ source
  • Akeso CEO looks beyond lung cancer with biliary tract win, counters ivonescimab debate
    Fresh off a phase 3 win in biliary tract cancer, Akeso CEO Michelle Xia, Ph.D., is touting the PD-1xVEGF bispecific antibody ivonescimab’s ability beyond non-small cell lung cancer, even as she con…
    Fierce Biotech · 7h ago↗ source
  • Hansoh heralds China’s move from ‘follower’ to ‘frontrunner’ in biopharma race
    Hansoh Pharmaceutical has given a bullish assessment of China’s innovative pharma sector, arguing that the industry is “fully transitioning from the ‘follower’ to the ‘frontrunner’ phase.”
    Fierce Biotech · 8h ago↗ source
  • JATT mastermind launches latest biotech-focused SPAC via $60M IPO
    Just two months after Someit Sidhu, M.D., succeeded in pairing off his second special purpose acquisition company (SPAC) with Talawar Therapeutics, the biotech entrepreneur is back at it again.
    Fierce Biotech · 8h ago↗ source
  • FDA greenlights Abbott’s wearable sensor for capturing diabetic ketoacidosis
    The FDA has approved Abbott’s first-of-its-kind bio-wearable sensor that can warn diabetics of increased ketones that can lead to diabetic ketoacidosis.
    Fierce Biotech · 9h ago↗ source
  • Boston Scientific hit by cyberattack causing ‘disruptions’ to parts of its business
    This year has seen a growing number of medtechs hit by cyberattacks, and now Boston Scientific has become the latest victim.
    Fierce Biotech · 10h ago↗ source
  • Spyre’s rheumatoid arthritis plan toppled by subpar TL1A data
    Phase 2 data on Spyre Therapeutics’ anti-TL1A antibody SPY072 in rheumatoid arthritis have fallen short of expectations, prompting the biotech to deprioritize monotherapy development in the indicat…
    Fierce Biotech · 12h ago↗ source
  • SK Biopharma pens $795M deal to usher Biohaven’s epilepsy therapy towards hoped-for 2029 launch
    SK Biopharmaceuticals has strengthened its epilepsy offering by paying $350 million upfront to help speed Biohaven’s Kv7 ion channel activator on its way to market.
    Fierce Biotech · 13h ago↗ source
  • Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
    ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use.
    fda medwatch · 14h ago↗ source
  • Baxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution Due to Potential Presence of Particulate Matter
    FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence…
    fda recalls · 17h ago↗ source
  • FDA expands Jazz's Ziihera to frontline HER2-positive gastroesophageal cancers, unlocking $1.5 billion market
    The U.S. Food and Drug Administration has broadened the approved use of Jazz Pharmaceuticals' cancer therapy Ziihera. The drug can now be given as an initial treatment for patients with HER2‑positi…
    BioPharma Dive · 20h agoApprovalPositive↗ source