FDAs Vaccines and Related Biological Products Advisory Committee unanimously votes (21 to 0) to recommend that Covid-19 vaccine composition be harmoni...
FDA permanently debars former Aegerion Pharmaceuticals sales representative Mark Moffett for his role in padding his sales bonuses by persuading physi...
Federal Register notice: FDA releases a final guidance entitled Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Feder...
Datascope/Getinge recalls its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to the risk of blood entering the devices through a damaged ...
Cancer researchers from FDA and academic medical centers report recommendations from a panel of experts convened to find ways to improve drug developm...
FDA lifts its clinical hold on an Inhibikase trial of its IkT 148-009 in Parkinsons disease.
FDA issues a BsUFA 3 regulatory science research roadmap highlighting areas where pilot demonstration projects could improve science-based recommendat...
The FDA Oncology Center of Excellence and Aetion open a five-year collaboration to research oncology real-world evidence sources.
