Novocure stops its LUNAR-4 study, a Phase 2 open-label trial testing Tumor Treating Fields together with Mercks Keytruda (pembrolizumab) in lung cance...
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 warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.
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.
