BridgeBio says FDA reviews NDA for infigratinib in achondroplasia
BBIO•FDA reviews BridgeBio’s NDA for infigratinib
- BridgeBio submitted a U.S. FDA NDA for oral infigratinib to treat achondroplasia.
- The company targets a U.S. launch in mid-2027, pending FDA review.
- EMA marketing application filing is expected in Q4 2026.
