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...
Cardiovascular Business reports that the American College of Cardiology has joined numerous other healthcare organizations in asking HHS to withdraw a...
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD chemotherapy for ad...
