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...
FDA releases the form FDA-483 with six observations from an inspection at the Minneapolis, MN-based IntegraDose Compounding Services outsourcing facil...
Integra LifeSciences recalls (Class 1) its Extended Tip Applicators due to sterility concerns.
FDA warns Orlando, FL-based Platinum Biologics that it is illegally marketing unapproved new drugs.
