ImmunityBio, Inc. 已向美国食品药品监督管理局(FDA)重新提交了其补充生物制剂许可申请(sBLA),该申请涉及将Anktiva®(nogapendekin alfa inbakicept)与卡介苗(BCG)联合用于治疗BCG无应答、伴有乳头状病变的非肌层浸润性膀胱癌(NMIBC)患者。此次重新提交是基于监管机构对额外数据的审查后进行的。
ImmunityBio, Inc. 已向美国食品药品监督管理局(FDA)重新提交了其补充生物制剂许可申请(sBLA),该申请涉及将Anktiva®(nogapendekin alfa inbakicept)与卡介苗(BCG)联合用于治疗BCG无应答、伴有乳头状病变的非肌层浸润性膀胱癌(NMIBC)患者。此次重新提交是基于监管机构对额外数据的审查后进行的。
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