Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components.
Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices based on patient-cen...
FDA approves Regnerons Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) in adults with fibrod...
FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, including personalized ca...
FDA warns Pomona, CA-based K.C. Pharmaceuticals about repeat CGMP violations in the production of over-the-counter drugs.
Merck and Moderna say a Phase 3 trial of Keytruda and intismeran autogene met key endpoints as an adjuvant melanoma treatment.
FDA warns Indias Auriga Research contract testing laboratory about CGMP violations in its testing of drugs for clients.
FDA publishes a guidance with frequently asked questions on the development of cellular and gene therapy products.
