RedHill Biopharma Ltd. (RDHL) Monday said the Food and Drug Administration or FDA has granted orphan-drug designation to its opaganib for the treatment of neuroblastoma, a type of childhood cancer.
Orphan Drug designation provides for a seven-year marketing exclusivity after the drug's approval, and other benefits including research grants, tax credits etc.
This is the second orphan drug designation by the FDA for opaganib in oncology, after cholangiocarcinoma or bile duct cancer.
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