FDA deputy commissioner for policy, legislation and international affairs Andi Fristedt says her office continues to have its sights on urging Congres...
FDA posts a draft guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases....
A Texas federal court sides with FDA in a lawsuit opposing the Covid-19 vaccines emergency use authorizations for use in children.
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Federal Register notice: FDA posts a draft guidance entitled Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ...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...
