Biofrontera's Ameluz Gets FDA Approval for Superficial Basal Cell Carcinoma Treatment

Biofrontera's Ameluz has been approved by the US FDA for the treatment of superficial basal cell carcinoma in adults, becoming the first PDT drug approved for a skin cancer and expanding its addressable market. The approval strengthens Biofrontera's position in medical dermatology and broadens the clinical utility of its Red-Light PDT platform. The company plans to launch the sBCC indication in late 2026 to early 2027 through its existing commercial organization and installed lamp base.