Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqy...
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 investigators cite contract research organization Cliantha Research over data integrity, documentation and clinical research deficiencies followin...
A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand human sensory perception...
