FDA Accepts for Review Treosulfan NDA Resubmission

FDA Accepts for Review Treosulfan NDA Resubmission

Source: 
BioSpace
snippet: 

On Thursday, June 6, 2024, Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) was informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the US Food and Drug Administration has accepted for review medac's April 2024 resubmission of the New Drug Application for treosulfan. Medexus expects that the FDA will complete its review of the treosulfan NDA and issue a decision by October 30, 2024.