News Related to Biofrontera

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FDA Clears SkinStylus for Periorbital Wrinkles; Accepts Biofrontera sNDA for sBCC; Belite Bio Completes Tinlarebant NDA

Jul 07, 2026

FDA clears SkinStylus for periorbital wrinkles across all skin types; accepts Biofrontera's sNDA for Ameluz PDT in superficial BCC with a September 2026 PDUFA date; Belite Bio completes rolling NDA submission for tinlarebant in Stargardt disease.

FDA Clears IND for Novel AML Degrader, Approves Prostate Cancer Imaging Agent, Accepts Skin Cancer Therapy Filing

Jun 15, 2026

The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.