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 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...
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...
FDA and drug-industry negotiators exchange early feedback on the agencys proposed America First fee incentives for domestic drug development during a ...
FDA approves Janssens Akeega a fixed-dose combination of niraparib and abiraterone acetate with prednisone for adults with metastatic castration-sen...
FDA approves Amgens Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis who test positive for anti-acetylcholine receptor or ant...
An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well and has several opp...
FDA approves the first at-home, prescription-only brain-stimulation device to treat major depressive disorder.
