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Minovia Therapeutics Says FDA Grants Fast Track Designation To MNV-201 For Myelodysplastic Syndrome


Minovia Therapeutics Says FDA Grants Fast Track Designation To MNV-201 For Myelodysplastic Syndrome

Israeli biotechnology company Minovia Therapeutics Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the Company's lead investigational compound, MNV-201 for Myelodysplastic Syndrome (MDS), a serious age-related hematopoietic disease.

This designation is in addition to the existing FDA Fast Track and Rare Pediatric Disease Designations for MNV-201 in the treatment of Pearson Syndrome, which is under Phase 2 clinical trial.

The designation provides Minovia with the opportunity for increased FDA interactions, potential eligibility for priority review, and the opportunity for a rolling submission of a future Biologics License Application (BLA) for MNV-201.

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