An Associated Press report says the nomination of Robert Califf to be FDA commissioner is in doubt due to opposition from both Democrats and Republica...
FDA approves a Sanofi BLA for Enjaymo (sutimlimab-jome) for decreasing the need for red blood cell transfusions due to hemolysis in adults with cold a...
Federal Register notice: FDA sends to OMB an information collection revision entitled Generic Drug User Fee Program.
Federal Register notice: FDA debars for five years Brenda K. Marmas from personally importing any drug into the U.S.
FDA tells Axsome Therapeutics that it will meet its inspection deadline on inspecting the companys contract manufacturing facility related to a 9/2021...
FDA publishes a draft guidance on the development of non-opioid analgesics for acute pain.
Eleven senators urge FDA to finalize its over-the-counter hearing aid rule quickly now that the public comment period has ended.
Three stakeholders comment on an FDA draft guidance on developing drugs to treat rhinosinusitis with nasal polyps.