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February 11, 2026 09:15 ET | Source: Biofrontera Inc.

Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma

Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026If approved, Ameluz® would be the first and only PDT photosensitizer indicated for the treatment of superficial...
October 14, 2024 10:30 ET | Source: Biofrontera Inc.

Biofrontera Inc. Announces Database Lock Of Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)

First Phase 3 PDT study in patients with sBCC in the United States.Rigorous dual endpoints requiring complete clinical and cytological clearance of malignant lesions.Data now being analyzed, interim...