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Sedaily
@sedaily.com
·
1 hour
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BREAKING NEWS
HLB 리보세라닙 또 FDA 문턱 못 넘어…“보완요구서한 받아”
HLB의 간암 치료제 리보세라닙이 미국 식품의약국(FDA) 허가 심사 문턱을 또 넘지 못했습니다. 신약허가신청(NDA)에 포함된 항서제약 제조시설 실사에서 지적사항이 발생했기 때문입니다. HLB는 미국 자회사 엘레바 테라퓨틱스를 통해 이 사실을 알렸습니다.
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