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651 stories matching this filter · ← front page

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  • Genentech pays $45M upfront to DualityBio for ADC platform targeting resistant cancers
    Genentech has agreed to pay DualityBio $45 million upfront for rights to its antibody‑drug conjugate (ADC) technology, with the agreement offering more than $1 billion in potential milestone paymen…
    Fierce Biotech · 16d agoDealPositive↗ source
  • 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 · 15d agoNegative readoutNegative↗ source
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Infectious Disease457
  • 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 · 16d agoRegulatoryNegative↗ source
  • 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 · 16d agoRegulatoryNegative↗ source
  • Everything Sprouts expands voluntary recall of Robust Radish Sprout Mix over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC announced an expansion of its voluntary recall to include additional lots of its 5‑oz Robust Radish Sprout Mix after identifying a potential contamination risk. The company…
    fda recalls · 15d 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 · 15d agoDealNeutral↗ source
  • Panorama Produce recalls 302 boxes of mangoes over possible Salmonella contamination
    Panorama Produce announced a recall of 302 boxes of size 9 mangoes because they may be contaminated with Salmonella. The recalled mangoes were distributed from August 10 to August 21, 2026 to Conn…
    fda recalls · 15d agoRegulatoryNegative↗ 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 · 16d 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 · 16d 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 · 17d 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 · 16d 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 · 16d 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 · 16d 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 · 16d 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 · 17d 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 · 17d agoCRLNegative↗ source
  • Ana Salazar Modela Tu Cuerpo recalls Lipofit Extreme Fat Burner 2.0 after FDA finds undeclared fluoxetine and DNP
    Ana Salazar Modela Tu Cuerpo Inc. announced a voluntary nationwide recall of its Lipofit Extreme Fat Burner 2.0 on August 27, 2026, targeting the lot with expiration in September 2027. FDA laborat…
    fda recalls · 16d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d agoPositive readoutPositive↗ source