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today announced that the U.S. Foodand DrugAdministration (FDA) has issued a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which ...
Oct 17 - The U.S. Foodand DrugAdministration has approved Avadel Pharmaceuticals' (AVDL.O), opens new tab sleep disorder drug for children aged 7 years and older, broadening its use and ...
to the U.S. Foodand DrugAdministration (FDA or Agency) for prademagene zamikeracel (pz-cel), its investigational autologous cell-based gene therapy, as a potential new treatment for patients ...