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MedPage Today

FDA Signals Regulatory Flexibility With Accelerated Approval of Rare Disease Drug

FDA Signals Regulatory Flexibility With Accelerated Approval of Rare Disease Drug

(MedPage Today) -- 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...

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