News Related to Aminolevulinic Acid Hydrochloride

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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.

FDA Accepts sNDA for Aminolevulinic Acid Gel in Superficial Basal Cell Carcinoma

Mar 09, 2026

The FDA has accepted a supplemental new drug application for aminolevulinic acid hydrochloride plus red light therapy for superficial basal cell carcinoma, with a decision date set for September 28, 2026.