FDA approves an expanded use for Medtronics Evolut transcatheter aortic valve replacement system, allowing implantation of a new Evolut valve inside a...
Ambu recalls (Class 1) its SPUR II resuscitators due to the manometer port being blocked, which causes the manometer to become non-functional.
FDA issues Telix Pharmaceuticals a complete response letter for its BLA seeking approval of Zircaix (89Zr-DFO-girentuximab), an investigational positr...
FDA sends Outlook Therapeutics a complete response letter on its resubmitted BLA for Lytenava (bevacizumab-vikg) for wet age-related macular degenerat...
AdventaPharma asks FDA to impose conditions on ANDAs referencing Ozempic to ensure an equivalent pen injector and active pharmaceutical ingredient.
FDA accepts Bayers NDA for gadoquatrane, a next-generation gadolinium-based contrast agent for use in magnetic resonance imaging.
In the wake of CDC director Susan Monarezs firing, Senate HELP Committee chair Bill Cassidy (R-LA) calls on HHS to postpone a just-announced Advisory ...
FDA says it is requiring a change in labeling for Eisai/Biogens Alzheimers drug Leqembi to call for an earlier MRI monitoring scan to identify patient...
