根据PDUFA的目标日期,预计2025年6月,美国FDA将对2款创新药物的批准做出监管决定,其中包括默沙东的合胞病毒单抗新药——Clesrovimab。Clesrovimab是一款在研的长效单克隆抗体,用于被动免疫预防RSV。Clesrovimab的设计特点是无论婴儿出生体重如何,都可以以相同的单次剂量进行给药,旨在为健康的早产儿、足月婴儿及高风险婴儿提供直接、快速且持久的保护,帮助他们在首个...
Source Link根据PDUFA的目标日期,预计2025年6月,美国FDA将对2款创新药物的批准做出监管决定,其中包括默沙东的合胞病毒单抗新药——Clesrovimab。Clesrovimab是一款在研的长效单克隆抗体,用于被动免疫预防RSV。Clesrovimab的设计特点是无论婴儿出生体重如何,都可以以相同的单次剂量进行给药,旨在为健康的早产儿、足月婴儿及高风险婴儿提供直接、快速且持久的保护,帮助他们在首个...
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