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FDA grants Evren Technologies a breakthrough device designation for its Phoenix earbud device and its use in treating post-traumat...[ Price : $8.95]
FDA issues Incyte a complete response letter on its BLA for retifanlimab, an intravenous PD-1 inhibitor for treating certain adult...[ Price : $8.95]
Federal Register notice: FDA announces a 9/2-3 Cellular, Tissue and Gene Therapies Advisory Committee meeting.[ Price : $8.95]
Federal Register notice: FDA rescinds a 1/15 notice that identified seven types of reserved Class 1 devices that HHS had determine...[ Price : $8.95]
FDA issues Iterum Therapeutics a complete response letter on its NDA for sulopenem etzadroxil/probenecid, indicated for treating t...[ Price : $8.95]
Federal Register notice: FDA extends the comment period for a 6/15 notice on: Exemption from Premarket Notification: Powered Patie...[ Price : $8.95]
Federal Register notice: FDA and the Clinical Trials Transformation Initiative request applications for patient advocates interest...[ Price : $8.95]
FDA revises a Manual of Policies and Procedures (MAPP) entitled Generic Drug Labeling Revisions Under Section 505(j)(10) of the Fe...