Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatment continues to demon...
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...
