News|Videos|September 16, 2026

What the FDA's Approval of Ameluz PDT Means for Skin Cancer

Fact checked by: Tim Smith

What does FDA approval of Ameluz PDT for superficial BCC mean for dermatology? Neal Bhatia, MD, weighs in on the first-of-its-kind decision.

This week, the US Food and Drug Administration (FDA) approved Biofrontera's supplemental new drug application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, implemented with the BF-RhodoLED lamp series, for the treatment of superficial basal cell carcinoma (sBCC) in adults, making it the first photodynamic therapy (PDT) regimen the agency has cleared for a skin cancer.¹

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