• FDA grants orphan drug designation to Gleolan for use in meningioma resection

    7 days ago - By Healio

    The FDA granted orphan drug designation to aminolevulinic acid hydrochloride, an optical imaging agent that helps visualize tumor tissue during resection of meningioma, according to a manufacturer-issued press release.
    Aminolevulinic acid hydrochloride is FDA approved for visualization of malignant tumor tissue of patients with glioma.
    Meningioma accounts for 36% of all primary brain tumors, affecting the membranes around the brain and spinal cord. Patients with meningioma often undergo surgical debulking to help manage this disease.
    A multicenter phase 3 study of
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