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丁香园
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拜耳非奈利酮美国获批用于心衰 - 丁香园
2025年3月,美国FDA给予非奈利酮用于治疗LVEF≥40%的成人心力衰竭患者新药上市申请(sNDA)优先审评资格。此次FDA批准是基于关键性FINEARTS-HF III期临床研究的阳性结果。该研究成果已经在2024年欧洲心脏病学会(ESC)大会上公布,并同步发表在《新英格兰医学杂志》上。在FINEARTS-HF研究中,非奈利酮在 ...
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