AEON Biopharma Inc:FDA支持AEON在351(K)生物类似药路径下的分析相似性策略

美股速递
Mar 25

美国食品药品监督管理局(FDA)已表态支持AEON Biopharma公司依照351(K)生物类似药审批路径所提出的分析相似性研究策略。这一积极信号意味着,AEON在推进其生物类似药研发过程中,所采用的关键技术路线获得了监管机构的认可。

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