FDA warns Malaysias Fulijaya Manufacturing about CGMP violations in its production of finished drugs.
A Friends of Cancer Research white paper explores the emerging role of AI-enabled tumor assessment tools and the framework needed to use them in valid...
A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regulated industries and s...
FDA lifts a clinical hold on Intellia Therapeutics MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran for patients with hereditary transthyreti...
FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subs...
Reuters reports that several drug companies say they are using artificial intelligence tools to speed up some of the time-intensive work needed for cl...
FDA approves a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma.
FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug outsourcing facility i...
