Ionis制药Zilganersen获FDA优先审评资格 PDUFA日期定为2026年9月22日

美股速递
Apr 21

Ionis Pharmaceuticals, Inc. 宣布其研发药物Zilganersen已获得美国食品药品监督管理局(FDA)的优先审评资格。该机构已将处方药用户付费法案(PDUFA)目标日期确定为2026年9月22日,标志着新药审评进程进入关键阶段。

优先审评资格通常授予那些在治疗严重疾病方面可能提供显著进展的药物,此举将标准审评周期从10个月缩短至6个月。Zilganersen此次获得的审评资格,预示着该药物在解决未满足医疗需求方面展现出重要潜力。

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