Abeona Therapeutics 完成了 pz-cel BLA 制造工厂的 FDA 许可前检查。 Abeona Therapeutics completes FDA Pre-License Inspection for pz-cel BLA manufacturing facility.
Abeona Therapeutics 完成了 FDA 对其制造工厂的许可前检查 (PLI)，该工厂涉及用于治疗隐性营养不良性大疱性表皮松解症 (RDEB) 的 pz-cel 生物制剂许可申请 (BLA)。 Abeona Therapeutics completes FDA Pre-License Inspection (PLI) for its manufacturing facility related to its Biologics License Application (BLA) for pz-cel for recessive dystrophic epidermolysis bullosa (RDEB). FDA还完成了斯坦福大学医学院和马萨诸塞大学医学院的临床研究现场检查。 The FDA has also completed clinical study site inspections at Stanford University School of Medicine and the University of Massachusetts Medical School. FDA 对 Abeona 的 pz-cel BLA 的审查正在进行中，目标处方药使用者付费法案 (PDUFA) 日期为 2024 年 5 月 25 日。 The FDA's review of Abeona's pz-cel BLA is ongoing, with a target Prescription Drug User Fee Act (PDUFA) date of May 25, 2024.