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Federal Register notice: FDA posts a draft guidance entitled Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ...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...
Indias BQ Prime financial news platform discloses five observations from an FDA inspection at an Alembic Pharmaceuticals non-sterile drug manufacturin...
