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Opaganib Granted Orphan-Drug Designation for Treatment of Neuroblastoma

Marks the second orphan-drug designation for RedHill Biopharma’s opaganib in oncology.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to RedHill Biopharma’s opaganib for treatment of neuroblastoma, a type of childhood cancer that develops from immature nerve cells and accounts for 15% of all pediatric cancer-related deaths.   Orphan Drug designation provides for a seven-year marketing exclusivity period should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant...

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