Biofrontera Inc. announced on September 14, 2026, that the U.S. Food and Drug Administration approved its supplemental New Drug Application for Ameluz topical gel combined with BF-RhodoLED lamp photodynamic therapy to treat superficial basal cell carcinoma in adults. This approval makes Ameluz the first and only photodynamic therapy drug authorized by the FDA for a skin cancer indication, expanding the addressable market from approximately 540,000 to 720,000 annual cases in the U.S. The company plans an official launch of this new indication between late Q4 2026 and early Q1 2027 using its existing commercial organization. Biofrontera Inc. is a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy products for dermatological conditions.