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Bayer says it will present positive results from a Phase 3 Nubeqa prostate cancer trial to FDA to consider a potential indication ...[ Price : $8.95]
FDA accepts for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel, indicated as monotherapy for treating...[ Price : $8.95]
The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type an...[ Price : $8.95]
FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs[ Price : $8.95]
FDA publishes a guidance on how it calculates combination product application user fees.[ Price : $8.95]
FDA accepts for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy fo...[ Price : $8.95]
FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.