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...
A new analysis from University of California (UC) Riverside and UC Irvine researchers finds that the vast majority of pivotal clinical trials used to ...
FDA and drug-industry negotiators exchange early feedback on the agencys proposed America First fee incentives for domestic drug development during a ...
