美国联合医疗公司宣布,将为旗下药物Tyvaso的补充新药申请(sNDA)寻求优先审评资格。该公司计划于今年夏季结束前向美国食品药品监督管理局(FDA)正式提交该项申请。
优先审评资格将加速FDA对Tyvaso申请的审批流程,若获批准,有望使该药物更早惠及患者。此次申报标志着公司在拓展Tyvaso适应症方面迈出关键一步。
美国联合医疗公司宣布,将为旗下药物Tyvaso的补充新药申请(sNDA)寻求优先审评资格。该公司计划于今年夏季结束前向美国食品药品监督管理局(FDA)正式提交该项申请。
优先审评资格将加速FDA对Tyvaso申请的审批流程,若获批准,有望使该药物更早惠及患者。此次申报标志着公司在拓展Tyvaso适应症方面迈出关键一步。
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