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FDA accepts for review a Retrophin NDA for a new formulation of its Thiola (tiopronin) tablets for treating cystinuria.[ Price : $8.95]
FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) as a maintenance treatment in ce...[ Price : $8.95]
Sen. Judiciary Committee chairman Chuck Grassley (R-IA) steps up pressure on FDA after a recent HHS Inspector General (OIG) report...[ Price : $8.95]
FDA grants Palvella Therapeutics a fast track designation for its lead product candidate PTX-022 (rapamycin topical formulation) f...[ Price : $8.95]
Pain Therapeutics appeals an August-issued FDA complete response letter for Remoxy, an abuse-deterrent, extended-release form of o...[ Price : $8.95]
FDA Review post the Federal Register notices for the week ending 11/9/2018.[ Price : $8.95]
FDA approves a Theravance Biopharma and Mylan NDA for Yupelri (revefenacin) inhalation solution for the maintenance treatment of p...[ Price : $8.95]
FDA issues Chembio Diagnostic Systems an emergency use authorization for its DPP Ebola Antigen System, a rapid, single-use test fo...