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11 天
ATX101 获得 FDA 突破性疗法认定 (BTD),用于治疗全膝关节置换术后疼痛
FDA 已授予 Allay Therapeutics 公司的 ATX101 突破性疗法认定 (BTD),这是一款用于治疗成人全膝关节置换术 (TKA) 后术后疼痛的试验产品。据该公司称,该认定基于 II 期临床试验的结果,该试验发现 ATX101 ...
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1 个月
疾病活动程度改善超70% 强生(JNJ.US)潜在重磅单抗获突破性疗法认定
智通财经APP获悉,强生(JNJ.US)日前宣布,美国FDA已授予其靶向新生儿Fc受体(FcRn)的在研抗体疗法nipocalimab突破性疗法认定(BTD),用于治疗中度至重度 ...
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