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Biofrontera Receives FDA Supplemental New Drug Application Approval For Its Ameluz Topical Gel, 10%, In Combination With Photodynamic Therapy Using The BF-RhodoLED Lamp Series For The Treatment Of Superficial Basal Cell Carcinoma In Adults

Sep 14, 2026 · 09:31 AM ET· updated 59m ago

With this approval, Ameluz becomes the first and only PDT drug approved by the FDA for the treatment of a skin cancer, and the only topical PDT in the United States indicated to treat both a pre-cancerous skin

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Why It Matters

Biofrontera got FDA approval for Ameluz to treat a type of skin cancer. This is the first and only drug like this approved, which could help the company sell more.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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