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The EMA decides whether medicines can be sold across the European Union. Gene therapies are assessed by a specialist committee, and the agency granted conditional marketing authorisation to the first CRISPR medicine in February 2024.
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The European Medicines Agency evaluates advanced therapy medicinal products through its Committee for Advanced Therapies. It granted conditional marketing authorisation to exagamglogene autotemcel in February 2024 for sickle cell disease and transfusion-dependent beta thalassemia in patients 12 and over for whom transplant is appropriate and no matched related donor is available.
Sources
- European Medicines Agency · 2024
Casgevy — European public assessment report ↗