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FDA accepts for priority review a bluebird bio BLA for betibeglogene autotemcel, a gene therapy for patients with β-thalassem...[ Price : $8.95]
FDA accepts for review an Obseva NDA for linzagolix for managing heavy menstrual bleeding associated with uterine fibroids in prem...[ Price : $8.95]
FDA grants Theradaptive a breakthrough medical device designation for its Osteo-Adapt SP Spinal Fusion implant indicated for trans...[ Price : $8.95]
FDA says it is making progress in the backlog of inspectional work needed to render review decisions on outstanding medical produc...[ Price : $8.95]
FDA releases the Establishment Inspection Report associated with a complete response letter issued to Revance Therapeutics on its ...[ Price : $8.95]
FDA issues two final orders reclassifying certain Hepatitis C virus diagnostic tests from Class 3 to Class 2.[ Price : $8.95]
Federal Register: FDA seeks comments on an information collection extension entitled Administrative Detention and Banned Medical D...[ Price : $8.95]
Federal Register notice: FDA corrects a 10/27 notice identifying the Web site where to find CDRHs fiscal year 2022 proposed guidan...