An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the agency's Section 503A ...
FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL.
Lilly says its triple hormone receptor agonist retatrutide met the primary weight loss endpoint in two Phase 3 trials.
Advocacy group Public Citizen files a petition urging FDA to ban prescription drug direct-to-consumer advertising.
FDA accepts for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with previously treated m...
Attorney Megan Robertsons analysis of 2026 FDA Warning Letters shows that CDER has been the most active Center, going after telehealth companies selli...
FDA releases the form FDA-483 issued following a 2026 inspection at the CSL Behring biological drug manufacturing facility in Marburg, Hessia, Germany...
FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated development, completing...
