由于提交了新的数据,Axogen神经移植应用软件被FDA延长到2025年12月。 Axogen's nerve graft application gets FDA extension until December 2025 due to new data submission.

林业发展局延长了Avance Nerve Graft的Axogen生物许可证申请三个月,将决定日期提前至2025年12月5日。 Axogen's Biologics License Application for its Avance Nerve Graft has been given a three-month extension by the FDA, pushing the decision date to December 5, 2025. 这一延迟是由于Axogen提交的新制造和设施数据,FDA认为这是一个需要额外审查时间的重大修改. This delay is due to new manufacturing and facility data submitted by Axogen, which the FDA considers a major amendment requiring additional review time. 林业发展局预计将在11月提供关于产品标签的反馈。 The FDA expects to provide feedback on product labeling in November.