原始出處紀錄
決策級PDUFA 日期確定
Biofrontera：FDA 將 Ameluz sNDA 用於 sBCC 的 PDUFA 日期定於 2026 年 9 月 28 日
FDA 已受理 Ameluz PDT 用於表淺性基底細胞癌的 sNDA，並指定 PDUFA 目標行動日期為 2026 年 9 月 28 日。這確立了一個近期監管決策點，可能擴大 Ameluz PDT 平台的核准適應症。
關鍵事實
來源摘錄
EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Biofrontera Inc. Reports First Quarter 2026 Financial Results and Provides a Business Update Woburn, MA (May 14, 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 months ended March 31, 2026 and provided a business update. First Quarter Financial Highlights ● Revenues for Q1 2026 were $10.1 million, a ~17% increase compared to $8.6 million for the same period in 2025. ● Gross margins were about 80%, an 18 percentage points increase compared to approximately 62% in Q1 2025, reflecting the first full quarter under the new earnout structure following
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重大
2026年3月19日
下午01:35
BFRIBiofrontera Inc.