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Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.
Taysha GeneTherapies announced that Queen’s University in Ontario, Canada, received Clinical Trial Application (CTA) approval from Health Canada for its Phase I/II trial of TSHA-101 for infantile GM2 gangliosidosis. RESTORE-1 is a Phase II trial of an intracerebral AAV-based genetherapy for Parkinson’s disease.
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