Federal Register notice: FDA announces a 5/8 Pulmonary-Allergy Drugs Advisory Committee meeting to review a Chiesi USA NDA for its cystic fibrosis dru...
FDA clears a SpineEX 510(k) for its Sagittae Lateral Lumbar Interbody (LLIF) Fusion System.
FDA issues Sun Pharmaceutical (Gujarat, India) a three-page Form 483 after a February inspection cited GMP deviations for finished pharmaceuticals.
Federal Register notice: FDA announces a 4/25 Antimicrobial Drugs Advisory Committee meeting to discuss approval of rabies virus monoclonal antibodies...
Federal Register notice: FDA makes available a draft guidance Rare Diseases: Natural History Studies for Drug Development.
FDA clears a BrightWater Medical 510(k) for the ConvertX Biliary Stent System for treating biliary obstructions.
Bayer and Janssen Pharmaceuticals agree to pay $775 million to settle about 25,000 claims against blood thinner Xarelto (rivaroxaban) and alleged seri...
FDA clears a Zimmer Biomet 510(k) for the Rosa One Spine System for robotically assisted spine surgeries.