FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on developing and using digitally derived measures in cl...
Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components.
Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.
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FDA releases a draft guidance that outlines recommendations for developing potency assays for active immunotherapy products, including personalized ca...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.
