FDA确认Cardiamp HF II研究或支持Cardiamp细胞疗法针对缺血性HFrEF的上市前批准_老虎社区_美港股上老虎

FDA确认Cardiamp HF II研究或支持Cardiamp细胞疗法针对缺血性HFrEF的上市前批准

美股速递06-05

美国食品药品监督管理局（FDA）已确认，Cardiamp HF II临床试验的结果，可能为BioCardia公司旗下Cardiamp细胞疗法用于治疗缺血性心力衰竭伴射血分数降低（HFrEF）的上市前批准（PMA）申请提供支持性数据。这一积极反馈标志着该创新疗法在监管审批路径上的关键进展，为后续正式提交PMA奠定了重要基础。

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