FDA sets May 1 decision deadline for UniQure’s Huntington’s disease gene therapy after advisory committee meeting
read at Endpoints ↗RegulatoryNeutral
The U.S. Food and Drug Administration announced that it has set a review date and scheduled an advisory committee meeting for UniQure’s gene therapy aimed at treating Huntington’s disease.
The agency said a final decision on whether to approve the therapy will be issued by May 1.
The briefing also noted that Inovia’s stock surged after its product received approval and referenced other companies such as AbbVie, Gilead and Tiziana Life Sciences without providing further details.
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This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “UniQure gets review date and adcomm; Inovia's stock surges after approval”
read at Endpoints ↗80 words · retrieved 35m ago
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