BridgeBio says FDA accepts encaleret NDA for ADH1, sets May 8, 2027 PDUFA date
Bitget2026/10/11 15:42- FDA accepted BridgeBio’s NDA for encaleret in autosomal dominant hypocalcemia type 1, granting Priority Review.
- PDUFA target action date set for May 8, 2027.
- Marketing authorization application filed with the EMA for the same indication.
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