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FDA posts two final guidances that provide recommendations to help clinical investigators comply with the safety reporting require...[ Price : $8.95]
The Government Accountability Office urges HHS to shore up staffing and reassess legal authorities at FDA after finding significan...[ Price : $8.95]
FDA approves Daiichi Sankyos Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentechs pertuzumab as a first-line t...[ Price : $8.95]
FDA posts updated guidance calling on drug and biologics developers to broaden eligibility criteria, modernize enrollment practice...[ Price : $8.95]
FDA considers adding a Boxed Warning to Covid-19 vaccines, the latest action as part of an ongoing campaign to scrutinize and rest...[ Price : $8.95]
FDA approves Amgens Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis who test positive for anti-acetylcho...[ Price : $8.95]
Senior FDA officials urge agency reviewers to speed up the review of Eli Lillys NDA for its oral weight loss pill orforglipron aft...[ Price : $8.95]
A new analysis from University of California (UC) Riverside and UC Irvine researchers finds that the vast majority of pivotal clin...