Federal Register notice: FDA corrects a 12/21/2023 notice announcing the availability of a final guidance entitled Development of Monoclonal Antibody ...
CDRH director Jeffrey Shuren says the Center will propose down-classifying many in vitro diagnostic tests from Class 3 to Class 2 in the hope of incre...
FDA and EMA schedule a 2/1 virtual public discussion on innovative therapies for some cancers to mark World Cancer Day.
FDA sends Defender Pharmaceuticals a complete response letter on its NDA for intranasal scopolamine (DPI-386) for preventing nausea and vomiting induc...
Neuralink founder Elon Musk announces the first chip implant in the brain of a human clinical trial participant.
Federal Register notice: FDA announces a 3/14 Oncologic Drugs Advisory Committee meeting to discuss a Geron NDA for imetelstat for injection.
Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.
Federal Register notice: FDA makes available a final guidance entitled Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Pr...
