FDA approves Genentechs Tecentriq (atezolizumab) as an add-on treatment following surgery and platinum-based chemotherapy for adults with Stage II-III...
Two Hyman, Phelps & McNamara attorneys take issue with FDAs new approach to regulate novel robot assisted surgery devices for specific indications rat...
Lupin recalls all irbesartan and irbesartan/hydrochlorothiazide tablets after finding some active pharmaceutical ingredient batches were above the spe...
An FDA advisory committee unanimously votes to recommend Johnson & Johnsons Covid-19 booster vaccine in all adults two months after receiving their in...
FDA delays its decision on expanding a Moderna emergency use authorization for its Covid-19 vaccine in adolescents while it further investigates myoca...
The Washington Post says three sources have indicated the Biden administration is close to bringing former FDA commissioner Robert Califf back into se...
FDA says the Abbott Molecular recall of two SARS-CoV-2 test kits is Class 1.
CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel describe initiatives under the Centers technology mo...