Source link : https://newshealth.biz/health-news/fda-signals-regulatory-flexibility-with-accelerated-approval-of-rare-disease-drug/
The FDA granted accelerated approval to tividenofusp alfa (Avlayah) for the treatment of mucopolysaccharidosis type II (MPS II), a rare disease also known as Hunter syndrome, the agency announced Wednesday. The IV infusion, given once weekly, is approved to treat neurologic manifestations of MPS II when started in presymptomatic or symptomatic pediatric patients weighing at […]
The post FDA Signals Regulatory Flexibility With Accelerated Approval of Rare Disease Drug first appeared on News Health.
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Author : News Health
Publish date : 2026-03-26 19:56:00
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