FDA grants Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agencys proposal to refuse approval of a supplemental N...
FDA cites a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad misleading and viola...
FDA posts a complete-response letter that outlined last month's rejection of Regenxbios BLA for its gene therapy clemidsogene lanparvovec.
Politico reports that HHS secretary Robert F. Kennedy Jr. said FDA will soon approve a way to make some peptides more accessible to the public.
FDA seeks public input on whether to revise a longstanding series of manufacturing guidance documents that govern how drugmakers manage postapproval c...
FDA publishes the International Council for Harmonization E2D(R1) guidance on management and reporting of postapproval individual case safety reports.
FDA posts the form FDA-483 issued following a 2024 inspection at Japans Fukuzyu Pharmaceutical Co.
FDA posts a new draft guidance entitled New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.
