An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten to set back public ...
14 states join a petition submitted by four other states calling on FDA to eliminate the mifepristone REMS requirements in their states or exercise di...
FDA grants Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne muscular dystrophy.
FDA publishes a guidance with recommendations for 510(k) animal studies for dental bone grafting material devices.
FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.
FDA announces a 10/23 public workshop to discuss the regulatory status of, and potential alternatives to, patch tests used in diagnosing allergic cont...
Nucleus RadioPharma appoints former FDA commissioner Stephen Hahn (Trump Administration 2019-2021) as its chief executive officer.
FDA issues enVVeno Medical a not-approvable letter for its PMA on VenoValve, a surgical replacement venous valve designed to treat severe deep chronic...
