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...
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.
