FDA expands its collaboration with CN Bio, adding research investigating the use of multi-organ microphysiological systems in estimating human drug bi...
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FDA posts a draft guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases....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Federal Register notice: FDA posts a draft guidance entitled Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ...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.
