FDA faces another Covid-19 debacle as it deals with over 1,300 Chinese firms providing medical protective equipment that registered in FDAs database w...
FDA Review posts product approval summaries for the week ending 6/21/2020.
FDA approves the expansion of a USGI Medical pilot study of it obesity-treating endoscopic procedure known as POSE 2.0.
Mylan says it is urging FDA to speed up its review of the companys ANDA for a generic copy of Biogens multiple sclerosis (MS) drug Tecfidera (dimethyl...
FDA posts a guidance entitled Good Manufacturing Practice Considerations for Responding to Covid-19 Infection in Employees in Drug and Biological Prod...
Federal Register notice: FDA announces a 7/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review a GlaxoSmithKline BL...
Federal Register notice: FDA corrects a 2/12/2019 notice that announced the withdrawal of approval of 12 ANDAs from multiple applicants.
FDA approves a 300 mg single-dose pre-filled pen for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab).