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 ...
FDA approves Janssens Akeega a fixed-dose combination of niraparib and abiraterone acetate with prednisone for adults with metastatic castration-sen...
FDA releases the form FDA-483 with two observations from an inspection at the Astellas Pharma sterile drug manufacturing facility in Takaoka, Toyama, ...
Eli Lillys investigational triple-agonist retatrutide shows substantial weight loss and meaningful reductions in knee osteoarthritis pain in a pivotal...
