林业发展局批准Axogen的神经移植,用于外围神经修复,等待确认性试验。 FDA approves Axogen’s nerve graft for peripheral nerve repair, pending confirmatory trials.

美国食品和药物管理局已批准Axogen®s AVANCE® (无细胞神经全移植- arwx) 作为加速批准途径,用于治疗成人和一个月及以上儿童的感觉,混合和运动外周神经缺口. The FDA has approved Axogen’s AVANCE® (acellular nerve allograft-arwx) under the Accelerated Approval pathway for treating sensory, mixed, and motor peripheral nerve gaps in adults and children one month and older. 根据神经功能在12个月替代端点上改善的情况,批准对高达25毫米的感官缺口和更大的缺口以及混合伤害和发动机伤害进行治疗,作为替代端点。 It is approved for sensory gaps up to 25mm and larger gaps, as well as mixed and motor injuries, based on improvements in nerve function at 12 months—a surrogate endpoint. 能否继续得到批准取决于是否进行确认性审判。 Continued approval depends on confirmatory trials. 该产品现在被归类为生物学产品,避免了收割病人神经组织的必要性,减轻了外科手术的负担。 The product, now classified as a biologic, avoids the need for harvesting patient nerve tissue, reducing surgical burden. 常见副作用包括程序疼痛和超麻醉。 Common side effects include procedural pain and hyperesthesia. 没有发生传染性传播。 No infectious transmissions have occurred. 商业发射预计于2026年初进行。 Commercial launch is expected in early 2026.