Biofrontera：FDA接受Ameluz PDT用于浅表基底细胞癌的sNDA；PDUFA日期为2026年9月

新闻稿称，FDA已完成备案审查并接受Ameluz PDT用于浅表基底细胞癌的sNDA。该受理将PDUFA目标行动日期定为2026年9月，为这一新适应症的监管路径推进奠定基础。

关键事实

申报时间: 2026年3月19日 13:35
事件: 申请已受理
方向: 积极
公司: BFRIBiofrontera Inc.
资产: Ameluz
来源: SEC 8-K
可信度: 有来源
日历: FDA 审批决定 (PDUFA) · 2026年9月28日 · 已批准

来源摘录

EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Biofrontera Inc. Reports Record Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update Conference call will be held today, Thursday, March 19 at 10:00 am ET Woburn, MA (March 19, 2026) (GLOBE NEWSWIRE) — Biofrontera Inc. (NASDAQ:BFRI) (the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three and twelve months ended December 31, 2025 and provided a business update. Fourth Quarter Financial Highlights ● Revenues for 4Q25 were a record $17.1 million, a 36% increase compared to $12.6 million for the same period in 2024. ● Gross margins were 82.4%, a roughly 2,400 basis point year over y

SEC 8-K