FDA approves Alexion Pharmaceuticals Ultomiris (ravulizumab-cwvz) 100 mg/mL, a new dosing formulation for treating adults with paroxysmal nocturnal he...
FDA clears a GE Healthcare 510(k) for the Ultra Edition package on its Vivid cardiovascular ultrasound systems, which includes new features based on a...
FDA Review posts the Federal Register notices for the week ending 10/09/2020.
FDA accepts for review a Foresee Pharmaceuticals 505(b)(2) NDA for Camcevi 42mg, a ready-to-use six-month depot formulation of leuprolide mesylate, in...
FDA grants Beckman Coulter an emergency use authorization for its Access SARS-CoV-2 Immunoglobulin M (IgM) assay.
FDA issues a revised Manual of Policies and Procedures on ANDA Suitability Petitions to clarify certain issues and include minor updates to the proces...
Federal Register notice: FDA withdraws approval of 13 NDAs from multiple applicants after they notified the agency that the drug products were no long...