BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia (GlobeNewswire) - Oct 6, 2026 - "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval...PROPEL 3, the global Phase 3 pivotal study of oral infigratinib in children with achondroplasia, met its primary endpoint..."
FDA filing • PDUFA • Priority review • Genetic Disorders
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