RDHL Redhill Biopharma

Opaganib của RedHill được FDA cấp chỉ định Rare Pediatric Disease cho bệnh u nguyên bào thần kinh (neuroblastoma)

FDA granted rare pediatric disease designation to opaganib for neuroblastoma, adding to its existing orphan drug designation. The new designation provides eligibility for a Priority Review Voucher and, together with orphan status, potential benefits including seven-year marketing exclusivity, accelerated review timelines, PDUFA fee waivers, and tax credits if approved.