Biofrontera's Supplemental New Drug Application For Ameluz Accepted By FDA

Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization and development of photodynamic therapy (PDT), today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted filing of the Company's supplemental New Drug Application (sNDA) for Ameluz® (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED® red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026.