# How Denali passed the FDA's new biomarker test for rare disease drugs - Date: 2026-03-25 - Category: Biotech & Life Sciences The Food and Drug Administration on Wednesday approved a new therapy from Denali Therapeutics for Hunter syndrome, clearing a drug that can do something no existing treatment for the disease has ever managed: reach the brain. Avlayah (tividenofusp alfa-eknm) is an enzyme replacement therapy desi... ---