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Biofrontera announces FDA acceptance of sNDA for Ameluz PDT

Biofrontera (BFRI) announced that the U.S. Food and Drug Administration has completed its filing review and accepted filing of the Company’s supplemental New Drug Application for Ameluz 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.

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