Find public news by keyword, exact ticker, category and date.
Open a ticker page for its news coverage. The news search below stays a text search.
3 results loaded, newest first. End of these results.
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. Disclaimer: This news brief was created by Public Techno
The FDA accepted BridgeBio’s NDA for oral infigratinib for children with achondroplasia and granted Priority Review. The PDUFA date is February 4, 2027.
BridgeBio won FDA Priority Review for its NDA of oral infigratinib to treat children with achondroplasia. PDUFA target action date set for Feb. 4, 2027. Approval would make infigratinib the first FDA-cleared oral therapy for achondroplasia.