百济神州(06160.HK):FDA受理百悦泽新适应症上市申请 获授优先审评
百济神州(06160.HK)公布,美国食品药品监督管理局(FDA)已受理「百悦泽」(泽布替尼)用於治疗先前接受过至少一项CD20导向疗法的成年边缘区淋巴瘤(MZL)患者的新适应症上市申请,并授予其优先审评资格,处方药申报者付费法案日期为2021年9月19日。
百济神州血液学首席医学官黄蔚娟表示,此为公司针对边缘区淋巴瘤提交的首项药政申请,未来几个月中不断与FDA进行沟通,继续推进针对百悦泽的全球临床开发项目。
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