FDA gives Sellas Life Sciences Group a Rare Pediatric Disease Designation for SLS009, a highly selective CDK9 inhibitor for treating pediatric acute m...
Federal Register notice: FDA announces that Argenxs supplemental NDA for Vyvgart Hytrulo for treating chronic inflammatory demyelinating polyneuropath...
FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.
FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs
FDA publishes a guidance on how it calculates combination product application user fees.
FDA accepts for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control i...
FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.
FDA commissioner Robert Califf says many stakeholders need to work together to improve interventions for common chronic diseases.
