FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi supplemental BLA for T...
Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.
FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate development of medical device...
A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in gener...
FDA asks manufacturers of generic Accutane to update the drugs labeling.
FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accelerated approval for t...
FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the U.S. regulator and ...
FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for treating neovascular ...
