Aquestive Therapeutics Inc. 实现关键监管突破:加拿大卫生部会议与欧洲审查进展推动 Anaphylm™ 舌下薄膜

华尔街洞察
15 Jul

Aquestive Therapeutics Inc. 在其 Anaphylm™(肾上腺素)舌下薄膜的全球扩张战略中迈出重要一步。公司已获得与加拿大卫生部的会晤机会,定于 2025 年第三季度举行,届时将深入讨论在加拿大的新药提交计划。与此同时,Aquestive 向欧洲药品管理局递交了初步简报文件,并即将提交正式的市场授权申请。此举彰显公司雄心:将 Anaphylm™ 打造为全球治疗严重过敏反应和过敏性休克的新标准疗法。依托其深厚的监管经验与商业化专长——旗下六种 FDA 批准药物覆盖六大洲——Aquestive 致力于突破治疗壁垒。Anaphylm™ 的口服给药方式巧妙化解了针恐惧症和设备故障等核心难题。

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