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458 stories matching this filter · ← front page

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  • 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 · 9h agoApprovalPositive↗ source
  • Revival Animal Health recalls two feline milk replacer products over low vitamin and mineral levels
    Revival Animal Health of Orange City, Iowa announced a voluntary recall of its Breeder’s Edge and Shelter’s Choice feline milk replacers. Testing revealed the products contain lower than expected…
    fda recalls · 9h agoCRLNegative↗ source
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Infectious Disease381
  • 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 · 19h 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 · 19h ago↗ source
  • Baxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution Due to Potential Presence of Particulate Matter
    FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence…
    fda recalls · 22h ago↗ source
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 1d agoApprovalPositive↗ 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 · 1d 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 · 1d 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 · 1d agoRegulatoryNegative↗ source
  • Baxter Recalls One Lot of 70% Dextrose Injection Over Stainless Steel Particulate Risk
    Baxter International announced a voluntary recall of a single lot of its 70% Dextrose Injection after detecting potential stainless steel particles in the solution. The presence of these particles…
    fda recalls · 1d agoCRLNegative↗ source
  • FDA issues warning letters to drug manufacturers in India, China and US over GMP violations
    The FDA has sent formal warning letters to several companies located in India, China and the United States. The letters cite multiple breaches of current good manufacturing practice standards in t…
    raps · 1d agoRegulatoryNegative↗ source
  • Better Bakehouse recalls Donutful chocolate‑dipped vanilla cake donuts over undeclared milk allergen
    The Better Bakehouse Snack Company announced a recall of certain lots of its Donutful Chocolate Dipped Vanilla Cake Donuts because the product may contain undeclared milk, creating a serious risk f…
    fda recalls · 1d agoCRLNegative↗ 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 recalls · 1d ago↗ source
  • Jaime’s Foods ATX Issues Allergy Alert on Undeclared Egg Allergen in Jaime’s Spanish Village Jalapeno Ranch
    Jaime’s Foods ATX of Austin, TEXAS is recalling Jaime’s Spanish Village Jalapeno Ranch because it contains undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of…
    fda recalls · 1d ago↗ source
  • FDA alerts users to destroy AVID Medical IV start kits containing recalled BD ChloraPrep applicators due to fungal contamination risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert warning that certain AVID Medical convenience kits may pose a high‑risk fungal contamination problem because they contain…
    fda medwatch · 2d agoRegulatoryNegative↗ source
  • FDA issues early alert on CooperSurgical infant nasal CPAP devices with loose tubing connection
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert about a potential high-risk issue with certain CooperSurgical infant nasal CPAP devices. The problem involves a loose…
    fda medwatch · 2d agoRegulatoryNegative↗ source
  • FDA alerts to potential fungal contamination in Medline kits containing recalled BD ChloraPrep applicators
    The Center for Devices and Radiological Health (CDRH) has issued an Early Alert to warn the public about a possible high-risk device problem involving Medline convenience kits. Medline has sent a…
    fda medwatch · 2d agoRegulatoryNegative↗ source
  • FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted again
    The U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA asks industry input on competency-based rules for generative AI medical devices
    The FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA finalizes guidance on therapeutic equivalence evaluations for ANDAs
    The U.S. Food and Drug Administration has issued final guidance describing its approach to therapeutic equivalence (TE) evaluations and the assignment of TE codes for abbreviated new drug applicati…
    raps · 2d agoRegulatoryNeutral↗ source
  • Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
    The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
    fda medwatch · 2d agoRegulatoryNeutral↗ source
  • Australian regulator TGA opens consultation on automated decision making for listed medicine variations
    The Therapeutic Goods Administration has launched a public consultation to gather input on proposed changes that would enable automated decision making for variation applications of listed medicine…
    raps · 2d agoRegulatoryNeutral↗ source
  • Everything Sprouts recalls alfalfa sprouts over possible E. coli and Salmonella contamination
    Everything Sprouts, LLC, a Minneapolis‑based producer, announced a recall of certain lots of its alfalfa sprouts on August 22, 2026. The recall was triggered because the sprouts may be contaminate…
    fda recalls · 4d agoCRLNegative↗ source
  • Vitruvias Therapeutics recalls one lot of 30 mg thyroid tablets over super potency risk
    Vitruvias Therapeutics announced a voluntary recall of a single lot (Lot No. 504950) of its 30 mg thyroid tablets to the consumer level. Testing confirmed the tablets could be superpotent, raising…
    fda recalls · 5d agoCRLNegative↗ source
  • FDA issues early alert on Medical Action epidural kits containing recalled sodium chloride ampules
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert warning about certain epidural kits from Medical Action Industries. The alert notes that the kits include sodium chlor…
    fda medwatch · 5d agoRegulatoryNegative↗ source