FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) as a maintenance treatment in certain patients with ...
Sen. Judiciary Committee chairman Chuck Grassley (R-IA) steps up pressure on FDA after a recent HHS Inspector General (OIG) report said FDA should tak...
FDA grants Palvella Therapeutics a fast track designation for its lead product candidate PTX-022 (rapamycin topical formulation) for treating pachyony...
Pain Therapeutics appeals an August-issued FDA complete response letter for Remoxy, an abuse-deterrent, extended-release form of oxycodone.
FDA Review post the Federal Register notices for the week ending 11/9/2018.
FDA issues Chembio Diagnostic Systems an emergency use authorization for its DPP Ebola Antigen System, a rapid, single-use test for the detection of E...
U.S. Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) send a letter to the President urging him to support legislation to limit anticompetitive pa...
After several years of planning, FDA says it implementing its New Inspection Protocol Project to modernize inspections with a new way of assessing, re...