Medexus Pharmaceuticals Inc (TSE:MDP) has released an update.
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Medexus Pharmaceuticals has announced that the FDA has extended the review period for the New Drug Application (NDA) of treosulfan, a drug intended for use in stem cell transplantation for leukemia and myelodysplastic syndromes, by three months with a new target action date set for January 30, 2025. The extension is due to the FDA needing more time to review additional analyses but does not require new clinical data. The company remains optimistic and is preparing for a potential approval and commercial launch in the first half of 2025.
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