FDA warns Dr. Bertrand Cole in Portsmouth, NH, about failing to conduct a clinical study according to the investigational plan.
FDA reverses course and agrees to review Modernas seasonal influenza mRNA vaccine after previously refusing to file the BLA.
The Sedgwick Recall Index year-end report for 2025 finds that the number of medical device recalls dropped compared to 2024, while drug recalls were s...
An FDA perspective in the New England Journal of Medicine outlines the agencys move away from requiring two pivotal trials for drug approval.
The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...
FDA warns Australias Cosmetics Manufacturers about CGMP violations in its production of drugs as a contract manufacturer.
Compass Pathways reports that its investigational psilocybin therapy met the primary endpoint in a second pivotal Phase 3 trial for treatment-resistan...
An FDA Early Alert says Trividia Health has issued updated use instructions for its True Metrix blood glucose monitors to emphasize the need to seek i...
