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...
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...
An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well and has several opp...
