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754 stories matching this filter · ← front page

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  • FDA approves Revolution Medicines' Rasonque for metastatic pancreatic cancer
    Revolution Medicines received FDA approval for its oral RAS inhibitor daraxonrasib, branded as Rasonque, to treat patients with metastatic pancreatic adenocarcinoma who have already received prior…
    Fierce Biotech · 12h agoApprovalPositive↗ source
  • 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 · 6h agoApprovalPositive↗ source
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Infectious Disease381
  • 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 · 9h 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 · 7h agoNegative readoutNegative↗ source
  • Hansoh says China’s biopharma is shifting from follower to frontrunner, now behind 30% of investigational drugs
    Hansoh Pharmaceutical used its first‑half earnings release to claim that China’s innovative biopharma sector is moving from a follower role to a frontrunner position. The company highlighted that…
    Fierce Biotech · 14h agoEarningsPositive↗ 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 · 10h agoPositive readoutPositive↗ source
  • Akeso reports phase 3 overall survival win for ivonescimab in advanced biliary tract cancer
    Akeso announced that its bispecific antibody ivonescimab combined with chemotherapy improved overall survival in a China phase 3 trial for advanced biliary tract cancer, beating the standard regime…
    Fierce Biotech · 13h agoPositive readoutPositive↗ source
  • Biotech entrepreneur Someit Sidhu launches JATT III Acquisition SPAC with $60M Nasdaq IPO
    Someit Sidhu, M.D., announced the formation of JATT III Acquisition, a new special purpose acquisition company that raised $60 million in an initial public offering on Nasdaq. The SPAC will seek t…
    Fierce Biotech · 14h agoDealNeutral↗ 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 · 15h 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 · 16h 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 · 19h 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 · 19h ago↗ source
  • Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed
    Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
    fda medwatch · 20h ago↗ source
  • Baxter Issues Voluntary Nationwide Recall for Two Lots of 0.9% Sodium Chloride Injection Due to Potential Presence of Particulate Matter
    FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling two lots of 0.9% Sodium Chloride Injection due to the potential presence of pa…
    fda medwatch · 20h 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 · 20h 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 · 1d agoApprovalPositive↗ 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
  • FDA clears Roche and Eli Lilly's blood test for early Alzheimer’s detection
    The U.S. FDA has granted clearance for a new blood test developed by Roche and Eli Lilly that measures phosphorylated tau 217 (pTau217) to help rule in or rule out Alzheimer’s disease. The Elecsys…
    BioPharma Dive · 1d agoApprovalPositive↗ source
  • Venture funding for women’s health startups drops sharply after 2024 peak, AI may drive rebound
    Venture capital flowing into women’s health companies fell sharply after reaching record levels in 2024. A Silicon Valley Bank report shows total funding dropped from about $3.2 billion in 2024 to…
    BioPharma Dive · 1d agoNeutral↗ source
  • FDA grants Capricor three-month extension to review DMD cell therapy data
    The U.S. Food and Drug Administration has given Capricor Therapeutics an additional three months to evaluate its Duchenne muscular dystrophy cell therapy after the agency asked for more information…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • FDA expands labels for J&J’s Imaavy and Jazz’s Ziihera; Teva under Turkish antitrust probe
    The U.S. Food and Drug Administration has broadened the approved uses for Johnson & Johnson’s oncology drug Imaavy and Jazz Pharmaceuticals’ Ziihera, adding new indications to each label. These la…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on potency testing for immunotherapy products
    The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to drugmakers in China, India and the US over GMP violations
    The U.S. Food and Drug Administration has issued warning letters to a number of manufacturers in China, India and the United States. The letters cite multiple violations of good manufacturing prac…
    raps · 2d agoRegulatoryNegative↗ source
  • Labcorp introduces reflex hepatitis D test to improve detection of severe viral hepatitis
    Labcorp has launched a new hepatitis D (HDV) reflex testing option as part of its Comprehensive Hepatitis Testing portfolio, aiming to close a gap in HDV monitoring. The test automatically adds HD…
    Fierce Biotech · 1d agoPositive↗ source