FDA sends 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 medications on their Web sites.
FDA publishes the International Council for Harmonization M14 guidance on planning, designing, analyzing, and reporting non-interventional studies usi...
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 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 recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its Huntingtons disease ...
