FDA accepts for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel, indicated as monotherapy for treating Epstein-Barr virus-...
The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type and world region.
FDA says a 4/1 Philips Respironics recall revising the use instructions for its OmniLab Advanced+ ventilator is Class 1.
FDA clears a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recovery images from alread...
FDA gives Sellas Life Sciences Group a Rare Pediatric Disease Designation for SLS009, a highly selective CDK9 inhibitor for treating pediatric acute m...
Federal Register notice: FDA announces that Argenxs supplemental NDA for Vyvgart Hytrulo for treating chronic inflammatory demyelinating polyneuropath...
FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.
FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs
