FDA reviewers raise issues with Capricor Therapeutics resubmitted deramiocel for treating cardiomyopathy in male patients with Duchenne muscular dystr...
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.
