The DC Circuit Court of Appeals says Sanofi was entitled to new chemical entity exclusivity for its Aubagio and Sandoz is not entitled to exclusivity ...
FDA announces a 3/8 workshop entitled Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Usi...
FDA approves Abbotts latest-generation transcatheter aortic valve implantation system, Navitor, for treating people with severe aortic stenosis.
FDA warns Chandler, AZ-based Optum Infusion Services about adulterated sterile drug products.
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FDA posts a draft guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases....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.
