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FDA批准Xembify治疗原发性免疫缺陷

2019-07-05 不详 m

Grifols是一家全球领先的血浆衍生药物生产商,近日宣布,其新的20%皮下免疫球蛋白Xembify®已获得美国食品和药品监督管理局(FDA)的批准用于治疗原发性免疫缺陷。

Grifols是一家全球领先的血浆衍生药物生产商,近日宣布,其新的20%皮下免疫球蛋白Xembify®已获得美国食品和药品监督管理局(FDA)的批准用于治疗原发性免疫缺陷。Grifols商业生物科学部总裁Joel Abelson表示:这项批准可以使我们更好地服务于患有原发性免疫缺陷的个体,加强了Grifols对患者和医疗保健专业人员的长期承诺。该公司计划在2019年第四季度在美国推出Xembify®,并正在与医疗机构合作,以获得加拿大、欧洲和其他市场的批准。

原发性免疫缺陷疾病是指主要由免疫系统遗传缺陷引起的疾病。已有多种单发性缺陷和联合缺陷性疾病被报道,包括体液免疫缺陷,严重联合免疫缺陷,以及由吞噬缺陷和补体缺陷引起的疾病。


原始出处:

http://www.firstwordpharma.com/node/1651323#axzz5slCedqVw

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    2019-07-26 bugit
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