FDA faces new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal Supreme Court decisio...
FDA approves a Bayer supplemental NDA to expand the labeling of Kerendia (finerenone) for reducing the risk of cardiovascular death, hospitalization f...
Edwards Lifesciences recalls its Optisite Arterial Cannula due to complaints received about its 3mm to 4mm section wire exposed/protruding from the ou...
FDA leaders say that the agency is currently conducting benefit-risk modeling studies based on the evolving risk of Covid-19 severe outcomes and the l...
FDA accepts for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update its label to reflect new data showing a s...
FDA issues Capricor Therapeutics a complete response on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duch...
FDA clears an Intuitive 510(k) for its Vessel Sealer Curved advanced energy instrumentation for use with its multiport da Vinci systems.
FDA announces a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future needs (e.g., guidan...
