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Received first FDA approval; advancing broad pipeline of BBB-crossing drugs
For decades, the blood-brain barrier has blocked nearly all large-molecule drugs from reaching the brain — a biological wall that left most neurological diseases effectively untreatable with modern biologics. On March 25, 2026, the Food and Drug Administration (FDA) approved AVLAYAH, developed by Denali Therapeutics, making it the first drug in history specifically engineered to cross that barrier and deliver a therapeutic enzyme to the central nervous system after a simple intravenous infusion.
Updated 4 hours ago
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