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  • BioNTech-Genentech halts colorectal cancer vaccine trial after higher death rate in vaccine arm
    BioNTech and Genentech stopped a phase 2 trial of their personalized mRNA vaccine BNT122 in patients with stage 2 or 3 colorectal cancer after an independent data safety monitoring board found more…
    Fierce Biotech · 17d agoNegative readoutNegative↗ source
  • FDA alerts on possible Aspergillus contamination in Avid Medical IV start kits
    The FDA’s Center for Devices and Radiological Health has issued an Early Alert warning that certain IV start kits from Avid Medical may be contaminated with the fungus Aspergillus penicillioides, a…
    fda medwatch · 17d agoRegulatoryNegative↗ source
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Infectious Disease464
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    FDA's CDRH issued an Early Alert about Boston Scientific's Imager II angiographic catheters due to a manufacturing problem that can cause the catheter tip to detach. The company sent a letter on A…
    fda medwatch · 17d agoRegulatoryNegative↗ source
  • Teva named stalking horse bidder to acquire BioXcel's neuroscience assets for $57.5 million
    BioXcel Therapeutics, a Connecticut biotech focused on neuroscience, filed for Chapter 11 bankruptcy after running out of cash to fund operations through August. In the filing, the company selecte…
    Fierce Biotech · 17d agoDealNeutral↗ source
  • CEPI pledges up to $16.5M to advance Egyptian biotech's Ebola vaccine candidate
    CEPI has committed up to $16.5 million to help bring Minapharm’s Bundibugyo Ebola vaccine candidate into clinical testing. The funding will support preclinical work and an early-stage human trial…
    Fierce Biotech · 18d agoDealPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 18d agoApprovalPositive↗ source
  • Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug
    Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
    Fierce Biotech · 18d agoCRLPositive↗ source
  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 18d agoRegulatoryPositive↗ source
  • UK reduces drug rebate rate to 14.5% after a year of pharma pull-back, following US trade deal
    In September 2025, relations between the UK government and major pharmaceutical companies hit a low point when the government announced a steep increase in the share of sales of new branded medicin…
    Fierce Biotech · 18d agoRegulatoryNeutral↗ source
  • Vivace Therapeutics appoints Craig Gibbs as CEO and Ellen Lubman as chief business officer ahead of phase 3 mesothelioma trial
    Vivace Therapeutics announced two senior leadership appointments. Craig Gibbs, Ph.D., will serve as the company’s president and chief executive officer, while Ellen Lubman joins as chief business a…
    Fierce Biotech · 18d agoPositive↗ source
  • Osivax licenses GC Biopharma seasonal flu vaccine to develop combined OVX836-GC FLU shot
    Osivax has secured a non-exclusive license from GC Biopharma for its seasonal influenza vaccine, GC FLU, to pair with Osivax’s mid-phase candidate OVX836. OVX836 targets the conserved nucleoprotei…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Medtronic and Given Imaging issue early alert for Bravo CF esophageal pH capsule delivery devices due to attachment failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert about a potential high‑risk issue with Medtronic’s Bravo CF esophageal pH monitoring capsule delivery devices. The proble…
    fda medwatch · 18d agoRegulatoryNegative↗ source
  • AVID Medical issues correction for convenience kits containing recalled Medline Namic Star Off-Handle manifolds
    AVID Medical has sent a letter to customers directing a correction of certain convenience kits that include manifolds affected by the Medline Namic Angiographic Star Off-Handle manifold recall. Th…
    fda medwatch · 18d agoCRLNegative↗ source
  • 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 · 19d agoApprovalPositive↗ source
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 19d agoApprovalPositive↗ 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 · 19d agoEarningsPositive↗ source
  • Spyre Therapeutics cuts rheumatoid arthritis program after weak Phase 2 TL1A antibody results
    Spyre Therapeutics reported that its Phase 2 study of the anti‑TL1A antibody SPY072 in rheumatoid arthritis did not meet the efficacy expectations set earlier this year. The company said the data f…
    Fierce Biotech · 19d agoNegative readoutNegative↗ source
  • SK Biopharma signs $795 million licensing deal with Biohaven for epilepsy therapy opakalim
    SK Biopharma has entered a licensing agreement with Biohaven Pharmaceuticals to acquire worldwide rights to the Kv7 ion channel activator opakalim (BHV-7000) for epilepsy. The deal provides an upf…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Flagship’s ProFound Therapeutics secures up to $35 M from Gates Foundation to discover preeclampsia drug targets
    Flagship Pioneering’s ProFound Therapeutics has entered a new partnership with the Gates Foundation that could provide up to $35 million for research. The agreement includes an initial $20 million…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Early Inclusion of China Boosts Global Biotech Clinical Development Efficiency
    Many global biotech firms still treat China as a later-stage commercial market, adding it only after key development decisions. This practice often forces costly bridging studies, extends timelines…
    Fierce Biotech · 19d agoPositive↗ 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 · 19d agoPositive readoutPositive↗ source
  • Deloitte urges advanced therapy makers to adopt AI-driven digital staff to overcome operational bandwidth limits
    Advanced therapy manufacturers are confronting an operational bottleneck as their pipelines expand rapidly. More than a thousand advanced therapies are in development and the U.S. patient pool is e…
    Fierce Biotech · 19d agoNeutral↗ source
  • FDA clears Abbott’s Libre Duo 10-Day sensor to warn of diabetic ketoacidosis
    The U.S. Food and Drug Administration has cleared Abbott’s new wearable device that measures both glucose and ketone levels in people with diabetes. The clearance allows the product to be marketed…
    Fierce Biotech · 19d agoApprovalPositive↗ source
  • Boston Scientific reports cyberattack that disrupts operations and order processing
    Boston Scientific disclosed in an SEC filing on Aug. 26 that it detected a cybersecurity incident the previous day, marking the latest medtech cyberattack of the year. The breach impacted several…
    Fierce Biotech · 19d agoNegative↗ source
  • Baxter recalls two lots of 0.9% Sodium Chloride Injection over possible fiberglass particles
    Baxter International announced a voluntary recall of two batches of its 0.9% Sodium Chloride Injection after detecting potential fiberglass particles in the solution. The company said the particul…
    fda medwatch · 19d agoCRLNegative↗ source