HLB said Elevar completed the FDA late-cycle meeting for lirafugratinib in previously treated FGFR2 fusion/rearrangement-positive cholangiocarcinoma without new approval-affecting review issues.
Korean translation
HLB는 리라푸그라티닙의 FDA 후기 심사 협의를 완료했으며 승인에 영향을 줄 새 검토 쟁점은 제기되지 않았다고 밝힘.