【biologics_license_application】什么意思_英语biologics_license_application的翻译_音标_读音_用法_例句_在线翻译

biologics license application

品许可申请

...A已给予该药物突破疗法资格，旨在用于治疗患有该疾病的婴儿，并且接受其进入生物制品许可申请（Biologics License Application）中的快速审批程序。

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申请

美国食品暨药物管理局（FDA）批准了Myozyme的生物制品许可申请(biologics license application，BLA)，Myozyme是首个治疗庞培氏病（Pompe）的药物。

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的生物制品许可申请

美国食品暨药物管理局（FDA）批准了Myozyme的生物制品许可申请(biologics license application，BLA)，Myozyme是首个治疗庞培氏病（Pompe）的药物。

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许可申请

美国食品暨药物管理局（FDA）批准了Myozyme的生物制品许可申请(biologics license application，BLA)，Myozyme是首个治疗庞培氏病（Pompe）的药物。

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短语

Instead of an NDA, new biologic drugs are approved using a Biologics License Application (BLA).

因此，与新药申请书不同，新的生物制品药物需填写生物制品许可申请(BLA)。

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更多双语例句

Consequently, they have expressed their intention to submit a new Biologics License Application (BLA) to obtain marketing approval, rather than an abbreviated submission via the biosimilars pathway.

FORBES: Do You Think 'Biosimilars' Will Reduce Healthcare Expenditures? Think again.
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has determined that additional time is required to complete the review of the biologics license application (BLA) for ipilimumab in pre-treated advanced melanoma, and has moved its decision date from December 25, 2010 to March 26, 2011.

FORBES: Immune-Boosting Cancer Drug Hits FDA Delay

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