Biofrontera Inc. (BFRI) said the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application for Ameluz topical gel in combination with the RhodoLED red-light lamp for the treatment of superficial basal cell carcinoma or sBCC.
The FDA identified no filing deficiencies and assigned a Prescription Drug User Fee Act or PDUFA target action date of September 28, 2026.
If approved, the new indication would mark a significant expansion of the Ameluz photodynamic therapy platform beyond its current approval for treating actinic keratosis. The therapy combines Ameluz's nanoemulsion technology with red-light illumination designed to penetrate deeper into tissue, enabling treatment of lesions extending into deeper skin layers.
Basal cell carcinoma is the most common cancer in the United States, with roughly 3.6 million cases diagnosed annually. Estimates indicate that about 10% to 25% of cases are of the superficial subtype. Current treatments often rely on surgical or destructive approaches, which may not be suitable for all patients.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.