Biofrontera wins FDA approval for Ameluz red-light PDT to treat superficial basal cell carcinoma

Reuters2026/09/14 13:26

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Biofrontera won FDA clearance for Ameluz topical gel with RhodoLED red-light PDT to treat superficial basal cell carcinoma in adults.
Label expansion positions Ameluz as the only FDA-approved photodynamic therapy for a US skin cancer indication.
Phase 3 trial showed 66% clinical-histological complete response at 12 weeks versus 5% for placebo-PDT.
Commercial launch planned for late Q4 2026 through Q1 2027 using the existing sales force and installed lamp base.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biofrontera Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609140926PRIMZONEFULLFEED9826207) on September 14, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Biofrontera wins FDA approval for Ameluz red-light PDT to treat superficial basal cell carcinoma

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