12:05 PM EST - Medexus Pharmaceuticals : And medac, a strategic partner of Medexus, are pleased to announce that medac has resubmitted its New Drug Application for Treosulfan (NDA) with the U.S. Food and Drug Administration (FDA). The NDA requests approval of Treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The resubmission includes additional clinical data and statistical analysis relating to the previously-completed phase 3 clinical trial of Treosulfan as well as an update of the integrated summary of safety, which the FDA had requested in their July 2021 Complete Response Letter to medac. Medexus Pharmaceuticals
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