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.
Federal Register notice: FDA publishes a list of information collections that have been approved by OMB.
Federal Register notice: FDA announces a 12/11 public meeting entitled Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI.
FDA accepts for review a Retrophin NDA for a new formulation of its Thiola (tiopronin) tablets for treating cystinuria.
FDA Review post the Federal Register notices for the week ending 11/9/2018.