FDA approves Abbotts latest-generation transcatheter aortic valve implantation system, Navitor, for treating people with severe aortic stenosis.
AstraZeneca says it is permanently discontinuing sales of Lumoxiti (moxetumomab pasudotox-tdfk) for injection, indicated for treating adults with rela...
FDA and CDC dismiss a recent potential safety signal suggesting Pfizers bivalent Covid-19 vaccine may cause ischemic stroke in people aged 65 and olde...
Federal Register notice: FDA posts a draft guidance entitled Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ...
Federal Register notice: FDA classifies digital therapy devices used to reduce sleep disturbance for psychiatric conditions into Class 2.
Medtronics Coviden unit recalls its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking condition within the hu...
FDA approves a Novo Nordisk label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg for a first-line treatment option for adults with Type 2 dia...
Kambiz Youabian (Tarzana, CA) pleads guilty to a two-count information charging him with mail fraud and introducing misbranded medical devices into in...
