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  • FDA approved an updated Ameluz label with hypersensitivity warningsSep 11, 2026

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  • Biofrontera submits an sNDA to the FDA to expand Ameluz red-light PDT to actinic keratoses across the full bodyOct 8, 2026
  • FDA approved Ameluz Red Light PDT from Biofrontera for treating superficial basal cell carcinomaSep 15, 2026
  • Biofrontera reported positive Phase 2b results supporting further development of Ameluz photodynamic therapy for moderate to severe acneMar 10, 2026
  • Biofrontera reported positive Phase 3 results for Ameluz photodynamic therapy in actinic keratoses across extremities, neck, and trunk, meeting the primary endpointFeb 10, 2026
  • Biofrontera Inc. announced database locks for two clinical studies supporting key milestonesJan 8, 2026

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