FDA accepts for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migraine headaches with o...
Federal Register notice: FDA issues a final rule that outlines requirements for premarket tobacco product applications and requires manufacturers to m...
Federal Register notice: FDA and HHS revise proposal requests for reimporting insulin and the personal importation of prescription drugs.
FDA denies a GlaxoSmithKline petition asking the agency to review specified information about its Zofran and indicate whether there should be labeling...
FDA approves Mercks Verquvo heart failure drug based on VICTORIA trial results.
The Peggy Lillis C. diff foundation asks FDA to take specific actions to improve the availability of microbiome treatments for C. difficile infections...
FDA notifies Histogen verbally of a coming clinical hold on its planned Phase 1/2 trial of HST-003.
Federal Register notice: FDA issues a final rule to provide additional information on the content and format of reports intended to demonstrate substa...