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English(EN) US regulator investigates tumour risk in children given Novartis gene therapy

美国FDA调查诺华基因疗法Zolgensma的肿瘤风险

美国食品药品监督管理局(FDA)正在调查诺华基因疗法Zolgensma可能存在的肿瘤风险。此前有报道称,接受该疗法治疗的儿童出现了包括恶性肿瘤在内的肿瘤。虽然FDA目前认为Zolgensma的益处大于风险,但在约6000名接受治疗的婴儿中出现九例肿瘤病例后,该机构正在考虑采取进一步行动。 AI

排序理由 监管机构对药品安全性的调查。[lever_c_降级,重要性:ic=1 ai=0.0]

在 SCMP — Tech 阅读 →

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美国FDA调查诺华基因疗法Zolgensma的肿瘤风险

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监管机构对药品安全性的调查。[lever_c_降级,重要性:ic=1 ai=0.0]
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报道来源 [1]

  1. SCMP — Tech TIER_1 English(EN) · Reuters ·

    美国监管机构调查诺华基因疗法在儿童中引发肿瘤的风险

    The US ⁠Food and Drug Administration said ⁠on Friday it was investigating a ⁠risk of neoplasia, or tumour formation including malignancy, associated with Novartis’ gene therapy Zolgensma. The Swiss drug maker earlier in the day disclosed two cases in which tumours in children sho…