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...
FDA defers a review action on GlaxoSmithKlines PD-1 drug dostarlimab, indicated for treating endometrial cancer, because it could not conduct a manufa...
A Vanity Fair special report examines how former FDA commissioner Stephen Hahn became the most politicized commissioner in recent history and describe...