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Biofrontera Inc. (BFRI) Files sNDA to Expand Ameluz PDT to Full-Body AKs
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Biofrontera submitted an sNDA to the FDA to expand Ameluz red-light PDT for mild-to-moderate AKs to extremities, neck and trunk, with an adjusted illumination protocol. FDA will first conduct a 60-day filing review. Material Details #DetailAI Analyst View1sNDA submitted to expand Ameluz AK labelRegulatory expansion could materially increase the treatable patient pool and revenue opportunity.2Targets extremities, neck and trunkMoves beyond face/scalp to broader field…