Federal Register notice: FDA issues a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative de...
Federal Register notice: FDA issues a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for...
Federal Register notice: FDA extends the comment period for a 9/24 over-the-counter monograph proposed order until 12/27.
FDA accepts for priority review a bluebird bio BLA for betibeglogene autotemcel, a gene therapy for patients with β-thalassemia across all genoty...
FDA accepts for review an Obseva NDA for linzagolix for managing heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
FDA grants Theradaptive a breakthrough medical device designation for its Osteo-Adapt SP Spinal Fusion implant indicated for transforaminal lumbar int...
FDA says it is making progress in the backlog of inspectional work needed to render review decisions on outstanding medical product applications that ...