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FDA warns Omaha, NE-based Cohere Beauty about CGMP violations in its Health Specialty drug manufacturing facility in Santa Fe Spri...[ Price : $8.95]
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 commissioner Robert Califf and associate commissioner for womens health Kaveeta Vasisht tout successes of the agencys Office o...[ Price : $8.95]
Eisai opens a rolling BLA submission for an autoinjector to deliver maintenance doses of Leqembi in patients with early Alzheimers...[ Price : $8.95]
Parenteral Technologies asks FDA to ban specific language from the directions for some liquid acetaminophen products indicated for...[ Price : $8.95]
FDA clears an Atraverse Medical 510(k0 for its Hotwire radiofrequency guidewire, a device that enables zero exchange left-heart ac...