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785 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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  • 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
  • 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
  • FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
    The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanc…
    fda press · 3h ago↗ 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 · 6h 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 · 13h 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
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 1d agoApprovalPositive↗ source
  • Eli Lilly launches oral obesity drug Foundayo in the UK
    Eli Lilly has introduced its oral weight‑loss pill Foundayo to the United Kingdom market, positioning the small‑molecule therapy as a price‑sensitive alternative to injectable options. The UK Medi…
    BioSpace · 1d agoRegulatoryPositive↗ source
  • Sentivera secures up to $1.5 billion licensing deal for inflammatory disease candidate
    Sentivera, a biotech startup formed by investors behind Metsera, announced a licensing agreement with Shanghai-listed Haisco Pharmaceutical. Under the deal, Sentivera will pay Haisco $40 million u…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Implantica receives FDA approval for RefluxStop GERD implant after eight years since EU launch
    Implantica announced that the U.S. Food and Drug Administration has granted approval for its gastroesophageal reflux disease (GERD) implant, RefluxStop, following a rigorous Premarket Approval revi…
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • Haisco partners with US VCs to launch immunology biotech Sentivera with up to $1.5B funding
    Haisco Pharmaceutical Group announced the creation of a new immunology-focused biotech called Sentivera, backed by two American venture‑capital firms, Population Health Partners and ARCH Venture Pa…
    BioSpace · 1d agoDealPositive↗ source