Catalyst Event
Amgen Inc (AMGN) · Other
From Akros U.S. Large Cap 500 Protective Allocation Monthly Index (A500PAM)
6/29/2026, 12:00:00 AM
Deadline for Amgen to submit detailed data, including an independent analysis by Duke Clinical Research Institute, to the FDA to justify a hearing regarding the agency's proposal to withdraw approval for the drug Tavneos. The proposal is based on safety concerns and alleged trial data manipulation by the drug's original developer. The submission is scheduled.
Korean Translation
FDA의 약물 타브네오스(Tavneos) 승인 철회 제안에 대한 공청회를 정당화하기 위해, 듀크 임상 연구소의 독립적인 분석을 포함한 상세 데이터를 FDA에 제출해야 하는 마감일. 이 제안은 안전성 우려와 약물의 최초 개발사에 의한 임상 데이터 조작 혐의에 근거함. 제출 예정됨.
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