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FDA Approves Label Update For Biofrontera’s Ameluz Gel To Highlight Hypersensitivity Warnings
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On Thursday, Biofrontera (NASDAQ:BFRI) discussed second-quarter financial results during its earnings call. The full transcript is provided below. This content is powered by Benzinga APIs. For comprehensive financial
Biofrontera shares are trading lower. The company announced that the FDA has approved its sNDA for Ameluz topical gel for the treatment of superficial Basal Cell Carcinoma in adults.
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
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