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  • Kofinas Olive Oil voluntarily recalls garlic-infused extra virgin olive oil over unapproved essential oil
    LMSI LLC/Kofinas Olive Oil announced a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil because it contains a garlic essential oil not approved for culinary use. The pro…
    fda recalls · 13d agoCRLNeutral↗ source
  • Northwest Naturals recalls frozen cat and dog chicken diets over possible Salmonella and Listeria contamination
    Northwest Naturals of Portland, Oregon announced a voluntary recall of two frozen pet food products after detecting possible bacterial contamination. The recall includes 53 cases (1,272 lb) of fro…
    fda recalls · 16d agoCRLNegative
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Infectious Disease459
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  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 16d agoApprovalPositive↗ source
  • AusperBio secures $120 million Series C to push hepatitis B antisense therapy into Phase 3
    AusperBio Therapeutics announced it has closed a $120 million Series C financing round aimed at moving its hepatitis B antisense oligonucleotide candidate toward late‑stage trials and eventual mark…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Roche pays $190 million for rights to Hanmi's UCN2 analog targeting obesity with muscle-preserving effects
    Roche's Genentech unit has agreed to pay $190 million upfront for rights to HM17321, a urocortin‑2 analog developed by South Korea’s Hanmi Pharmaceutical, covering markets outside South Korea. The…
    Fierce Biotech · 17d agoDealPositive↗ source
  • 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 · 17d 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 · 16d 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
  • 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
  • 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 · 16d 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
  • 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 · 16d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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
  • 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 · 17d 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 · 18d 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 · 18d 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