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FDA取消自体CAR-T细胞免疫疗法风险评估与缓解策略(REMS)
2025年6月27日美国食品药品监督管理局 (FDA)宣布,取消当前已获批的BCMA及CD19靶向自体嵌合抗原受体 (CAR)T细胞免疫疗法的风险评估与缓解策略 (risk evaluation and mitigation strategy,REMS)要求。FDA认定无需REMS即可确保此类免疫疗法的安全性与有效性。
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