FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data without requiring ident...
FDA posts two final guidances that provide recommendations to help clinical investigators comply with the safety reporting requirements for IND and ID...
The Government Accountability Office urges HHS to shore up staffing and reassess legal authorities at FDA after finding significant weaknesses in how ...
FDA approves Daiichi Sankyos Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentechs pertuzumab as a first-line treatment for adults ...
FDA posts updated guidance calling on drug and biologics developers to broaden eligibility criteria, modernize enrollment practices, and adopt more fl...
FDA considers adding a Boxed Warning to Covid-19 vaccines, the latest action as part of an ongoing campaign to scrutinize and restrict use of the vacc...
FDA approves Amgens Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis who test positive for anti-acetylcholine receptor or ant...
Senior FDA officials urge agency reviewers to speed up the review of Eli Lillys NDA for its oral weight loss pill orforglipron after the drugmaker pus...
