BridgeBio says FDA accepts infigratinib NDA for achondroplasia, grants priority review
- BridgeBio NDA for oral infigratinib in children with achondroplasia accepted by FDA for Priority Review.
- PDUFA target action date set for Feb. 4, 2027.
- PROPEL 3 Phase 3 study supported filing, showing a +2.10 cm/year annualized height-velocity treatment effect.
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