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FDA gives Sellas Life Sciences Group a Rare Pediatric Disease Designation for SLS009, a highly selective CDK9 inhibitor for treati...[ Price : $8.95]
Federal Register notice: FDA announces that Argenxs supplemental NDA for Vyvgart Hytrulo for treating chronic inflammatory demyeli...[ 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FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.[ Price : $8.95]
FDA commissioner Robert Califf says many stakeholders need to work together to improve interventions for common chronic diseases.