FDA Clears Denali's AVLAYAH, the First Brain-Penetrating Enzyme Therapy, Cracking Hunter Syndrome's Neurologic Frontier After Two Decades
Denali's tividenofusp alfa becomes the first FDA-approved biologic engineered to cross the blood-brain barrier, breaking a long rare-disease rejection streak and validating a transport-vehicle platform that could unlock CNS access for many more drugs.
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