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  • Novartis and Bristol Myers pause autoimmune CAR-T trials after safety concerns
    Novartis announced a temporary hold on its personalized CAR-T therapy rap-cel after three patients experienced immune effector cell-associated hemophagocytic syndrome, a rare and potentially life-t…
    BioPharma Dive · 13d agoRegulatoryNegative↗ source
  • Verily, NVIDIA and NIH launch first multimodal AI model combining EHR and genomics
    Verily Health, in partnership with NVIDIA and the NIH All of Us Research Program, announced the development of a new foundation model that merges electronic health record data with genomic informat…
    BioPharma Dive · 14d agoPositive↗ source
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  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 14d agoRegulatoryNeutral↗ source
  • Crystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs
    Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run th…
    fda recalls · 14d agoRegulatoryNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 14d agoRegulatoryNeutral↗ source
  • India streamlines regulations for outsourced medical device sterilization
    The Indian government announced a simplification of the regulatory framework governing outsourced sterilization of medical devices. The move is part of a broader effort to make it easier for busine…
    raps · 14d agoRegulatoryPositive↗ source
  • 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 · 14d 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↗ source
  • FDA approves Priovant's Lisraya (brepocitinib) for rare skin disease dermatomyositis
    The U.S. Food and Drug Administration has cleared the first oral targeted treatment for dermatomyositis, a rare and disabling skin disorder. The medication, brepocitinib, will be sold under the br…
    BioPharma Dive · 17d agoApprovalPositive↗ source
  • FDA clears updated COVID shots from Pfizer, Moderna and Novavax as Moderna raises $2.6 billion for cancer programs
    The FDA has granted limited approvals for updated versions of three COVID-19 vaccines aimed at the newly dominant XFG variant. The clearances cover Pfizer/BioNTech’s Comirnaty, Moderna’s mNEXSPIKE…
    BioPharma Dive · 17d agoRegulatoryPositive↗ source
  • Biotech Index Surges as IPOs and M&A Activity Accelerate in 2026
    The XBI biotech index, which had fallen to about $64 per share three years ago, has climbed back to near $170, almost doubling its value over the past year. Investor interest is reflected in a wav…
    BioPharma Dive · 17d agoPositive↗ 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
  • FDA sends warning to Alar over misleading claims about investigational depression drug
    The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion sent an untitled warning letter to Alar Pharmaceuticals. The agency says Alar’s promotional materials for ALA-3000, an…
    raps · 17d agoRegulatoryNegative↗ source
  • FDA considers two new executive posts and approves first-of-its-kind early drug and ketone‑glucose wearable
    The Health and Human Services department is reportedly evaluating the creation of two additional senior positions within the FDA, a step that could increase agency oversight. In recent approvals,…
    raps · 17d agoRegulatoryNeutral↗ 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 · 17d agoRegulatoryNegative↗ source
  • AstraZeneca, Ionis data spark debate about RNA drugs’ impact on deadly heart disease
    Results published in NEJM raised questions about the benefits “silencer” medications provide on top of standard therapies for TTR cardiomyopathy and amplified investor pressure on Alnylam.
    BioPharma Dive · 17d agoRegulatoryNeutral↗ 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 · 17d agoRegulatoryNegative↗ source
  • Revolution Medicines’ pancreatic cancer drug Rasonque priced at $39,800 a month, analysts predict blockbuster sales after swift FDA approval
    Revolution Medicines announced that its new pancreatic cancer therapy, Rasonque, received FDA approval in a rapid review process. The drug is priced at $39,800 for a 30-day supply, which translate…
    BioPharma Dive · 18d agoApprovalPositive↗ source
  • AstraZeneca and Amgen report positive Phase 3 results for Tezspire in eosinophilic esophagitis
    AstraZeneca and Amgen announced that their joint drug Tezspire met primary and secondary endpoints in a late-stage Phase 3 trial for eosinophilic esophagitis. The antibody targets TSLP and had pre…
    BioPharma Dive · 18d agoPositive readoutPositive↗ source
  • Outer Bio unveils skin‑tissue platform that keeps samples alive for a month, creating terabytes of data for skincare research
    Outer Bio, a new biotech founded by Michael Polansky, has emerged from stealth to offer a skin‑focused platform that maintains harvested human skin tissue alive for about a month. The company says…
    BioPharma Dive · 18d agoPositive↗ 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 review highlights expanding role of manufacturing process models in drug applications
    The FDA released a review outlining how manufacturers can incorporate process modeling into their regulatory submissions. Process models are described as a growing scientific area and are being us…
    raps · 18d agoRegulatoryNeutral↗ 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 · 18d agoCRLNegative↗ source