RedHill Biopharma Drug Gets FDA Boost for Treating Childhood Cancer
RedHill Biopharma's investigational drug opaganib has received FDA rare pediatric disease designation for treating neuroblastoma in children.
Source: tps.co.il
>>”>Jerusalem, 10 June, 2026 (TPS-IL) — Tel Aviv-based RedHill Biopharma has announced that the U.S. Food and Drug Administration has granted rare pediatric disease designation to its investigational drug opaganib for the treatment of neuroblastoma, a cancer primarily affecting infants and young children. The designation, added to its existing orphan drug status, may provide benefits including priority review vouchers, reduced regulatory fees, and potential seven-year market exclusivity if approved.
The company also highlighted recent preclinical data showing encouraging anti-cancer activity.
