原始来源记录
FDA已接受INOVIO的INO-3107 BLA并进行标准审评，PDUFA目标日期为2026年10月30日。该机构指出加速批准资格可能存在问题；INOVIO计划请求召开会议以解决此问题，且不寻求传统批准途径。目前未计划召开咨询委员会会议。
EX-99.1 2 d78035dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 FDA Accepts for Review INOVIO’s BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP) PLYMOUTH MEETING, PA., December 29, 2025 /PRNewswire/ — INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by FDA is Standard. The FDA assigned INO-3107 a Prescription Drug User Fee Act (PDUFA) review goal date of October 30, 2026, which