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Clinuvel Pharmaceuticals公司称,FDA取消了植入物的上市后要求

-- 据周一提交给澳大利亚证券交易所的文件显示,Clinuvel Pharmaceuticals(ASX:CUV)表示,美国食品药品监督管理局(FDA)在审查了其植入式心脏复极化装置Scenesse的长期安全性数据后,取消了对其进行上市后一期心脏复极化研究的要求。 Scenesse用于治疗红细胞生成性原卟啉病患者,这是一种导致光不耐受的疾病。 文件称,FDA认为该研究不再必要,因为它无法提供有价值的安全性信息。

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