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FINWIRES

Clinuvel Pharmaceuticals公司稱,FDA取消了植入物的上市後要求

-- 根據週一提交給澳洲證券交易所的文件顯示,Clinuvel Pharmaceuticals(ASX:CUV)表示,美國食品藥物管理局(FDA)在審查了其植入式心臟復極化裝置Scenesse的長期安全性數據後,取消了對其進行上市後一期心臟復極化研究的要求。 Scenesse用於治療紅血球生成性原卟啉症患者,這是一種導致光不耐受的疾病。 文件稱,FDA認為該研究不再必要,因為它無法提供有價值的安全性資訊。

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