AVLAYAH

Sep 07, 2026

Summary Diseases once dismissed as “too rare to matter” (hundreds to low‑thousands of patients globally) are now central to innovation, with regulators, payers, and major companies adapting fast. In the first eight months of 2026, the FDA cleared more than 6 first‑in‑class drugs, a pace that historically too...

Mar 30, 2026

Summary AVLAYAH (tividenofusp alfa‑eknm) has received FDA accelerated approval as the first Hunter syndrome therapy specifically designed to treat neurologic manifestations by crossing the blood–brain barrier. The drug uses Denali’s TransportVehicle platform to fuse the IDS enzyme with a transferrin‑receptor...