UX111
FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues
FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay
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FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay