原始来源记录

决策级FDA 批准

Regeneron Pharmaceuticals Inc · FDA 批准 OTARMENI (lunsotogene parvec-cwha)

FDA 的 Purple Book 将 BLA 125874 (OTARMENI, lunsotogene parvec-cwha; Regeneron Pharmaceuticals, Inc., CBER) 列为已于 2026-04-23 获得许可。

Regeneron Pharmaceuticals Inc · FDA 批准 OTARMENI (lunsotogene parvec-cwha) | SimianX AI