BridgeBio gets FDA Priority Review for achondroplasia drug
BridgeBio announced that the FDA has accepted its New Drug Application (NDA) for oral infigratinib for the treatment of children with achondroplasia, granting it Priority Review. The target action date is February 4, 2027. If approved, it would be the first oral targeted therapeutic option for this condition.
BridgeBio said the FDA has accepted its application for Priority Review, with a PDUFA target action date of February 4, 2027. The company said the designation underscores the unmet need for an oral targeted therapeutic option for children with achondroplasia. If approved, oral infigratinib would be the first and only ap…