FDA issues a new draft guidance on Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control that proposes to remove...
FDA accepts for review a Mylan/Biocon BLA for MYL-1402O, a biosimilar candidate referencing Genentechs Avastin (bevacizumab).
FDA announces a 4/3 public meeting entitled U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Counc...
FDA approves Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interstitial lung diseases ...
Federal Register notice: FDA seeks comments on an information collection extension for FDA Safety Communication Readership Survey.
FDA commissioner Stephen Hahn says that 1.1 million more coronavirus tests have just been shipped by nonpublic health labs.
FDA issues a final guidance on 510(k) submissions for electrosurgical devices.
FDA and FTC have issue seven Warning Letters to companies for allegedly selling fraudulent coronavirus products.