BioMarin· @BioMarin · X·· 2026-07-13精选AI 评分62
AI 导读
BioMarin 宣布美国 FDA 已受理其补充新药上市申请,用于该药物治疗软骨发育不全儿童患者的完全批准。该申请基于三项正在进行的长期扩展临床试验结果,公司称其包含软骨发育不全领域规模最大的疗效与安全性数据。更多信息见 http://ms.spr.ly/6011v0Z0h。
推荐理由
FDA 受理该补充上市申请,读者可了解软骨发育不全治疗在长期扩展试验中的疗效与安全性数据积累。
正文
We announced that the U.S. Food and Drug Administration has accepted BioMarin's supplemental New Drug Application for full approval of our medicine for children with achondroplasia.
The submission is supported by results from three ongoing long-term extension clinical trials, including the largest body of efficacy and safety data of any medicine studied in achondroplasia.
Learn more: http://ms.spr.ly/6011v0Z0h
来源:BioMarin · x.com