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The CDER Drug Trials Snapshop Summary Report 2023 provides statistics on the 55 novel drugs the Center approved in 2023.[ Price : $8.95]
FDA grants Juno Therapeutics accelerated approval for its BLA for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for ad...[ Price : $8.95]
Rep. Mark Green (R-TN) introduces the Vaccines in Trial and Liability Act of 2024 that would ensure Americans are protected from f...[ Price : $8.95]
FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.[ Price : $8.95]
Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approv...[ Price : $8.95]
FDA clears a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respirato...[ Price : $8.95]
FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.[ Price : $8.95]
United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredi...