FDA clears a Bright Uro 510(k) for its Glean Urodynamics System, a wireless, catheter-free ambulatory urodynamics device designed to support clinical ...
FDA approves Mirum Pharmaceuticals tablet formulation of Livmarli (maralixibat) for treating cholestatic pruritus.
Based on FDA recommendation, Ironwood Pharmaceuticals says it will conduct a new Phase 3 clinical trial for apraglutide for treating short bowel syndr...
Pfizer abandons the development of danuglipron, an experimental oral GLP-1 receptor agonist being evaluated for chronic weight management, due to safe...
FDA seizes several hundred units of counterfeit Ozempic (semaglutide) 1mg injection that had entered the U.S. drug supply chain.
Vanda Pharmaceuticals sues FDA seeking a declaratory judgment giving the company protection under the First Amendment to promote Hetlioz (tasimelteon)...
Former CBER director Peter Marks tells Time that he was seeing an increasing anti-vaccine tone before he resigned from the agency over pressure from t...
