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The FDA has approved an sBLA for deflazacort that expands the label to patients aged 2 to 5 with Duchenne muscular dystrophy.
The highly specific myostatin activation inhibitor is expected to enter phase 2 study in spinal muscular atrophy, according to SRK-015’s manufacturer, Scholar Rock.
The FDA has set a PDUFA date of March 25, 2020.
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