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FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.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...
FDA lifts a clinical hold on Rocket Pharmaceuticals pivotal Phase 2 trial of RP-A501, an investigational gene therapy for Danon disease.
Experts share varying opinions with Clinical Trials Arena on the impact of an FDA rule barring biotech companies from sending cells from U.S. patients...
