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RedHill's Opaganib Receives FDA Rare Pediatric Disease Designation for Neuroblastoma in Addition to Current Orphan Drug Designation

The U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation to opaganib1  for the treatment of neuroblastoma, a type of cancer most commonly affecting babies and young children -- Rare pediatric disease designation provides for a Priority Review Voucher (PRV) subject to certain conditions -- This new designation is in addition to opaganib's current neuroblastoma orphan drug…

PRNewsWire • Jun 9, 2026
RedHill Biopharma Advancing Opaganib Options for Novel Dual Host Directed and Direct Acting Antiviral Approach for Ebola Outbreak Biodefense Platforms

Amid the rapidly evolving Ebola virus disease (EVD) outbreak involving the rare Bundibugyo ebolavirus sub-type, for which there are no approved medications or vaccines, RedHill Biopharma is actively discussing potential collaborations for clinical advancement of opaganib 1 , including the World Health Organization's (WHO) SOLIDARITY CORE clinical trial platform Opaganib EVD rationale (analogous to EVD treatment…

PRNewsWire • Jun 2, 2026

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