FDA warns Thailands S&J International Enterprises about CGMP violations in its production of finished drugs and refusing to allow some records to be c...
The DC federal court orders FDA to act on a Vanda sNDA for a Hetlioz indication to treat jet lag disorder or schedule a hearing on the submission.
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...
