Catalyst Event
Amgen Inc (AMGN) · Other
From KEDI Tesla Fixed Tech100 Index (KTSLT100)
4/28/2026, 12:00:00 AM
The U.S. FDA's Center for Drug Evaluation and Research (CDER) proposed the withdrawal of approval for Amgen's autoimmune drug Tavneos on April 28, 2026, citing a lack of substantial evidence of effectiveness and alleging that the original application contained untrue statements and manipulated data.
Korean Translation
2026년 4월 28일, 미국 FDA 산하 약물평가연구센터(CDER)가 암젠의 자가면역질환 치료제 타브네오스(Tavneos)에 대해 효능에 대한 실질적 증거 부족 및 최초 신청서에 허위 진술과 조작된 데이터가 포함되었다는 이유로 승인 철회를 제안함.
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