FDA issues a Complete Response Letter to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combi...
FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotecti...
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...
