FDA issues Sunovion Pharmaceuticals a complete response letter rejecting its NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reup...
FDA approves Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older....
Federal Register notice: FDA announces a pilot meeting program to allow sponsors to discuss the use of complex innovative trial design approaches in m...
FDA grants Insys Therapeutics a fast track designation for its epinephrine nasal spray as an investigational treatment for anaphylaxis.
Chain drug stores urge FDA to withdraw a draft guidance on waivers for single, shared system REMS, and other stakeholders also critique it.
An online CDER post describes work of Center statistical researchers in developing complex innovative clinical trial designs.
FDA commissioner Scott Gottlieb says the agency is modernizing its approach to medical product regulation to support innovation in development of drug...
The New Jersey federal court approves a permanent injunction sought by FDA against several companies and their executives charged with illegally selli...