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- FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell DiseaseThe U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
- FDA issues warning letter to Sanofi's Genzyme Irish manufacturing site over quality and data integrity concernsThe U.S. Food and Drug Administration sent a warning letter late last month to the Ireland‑based manufacturing facility operated by Genzyme, which is now owned by Sanofi. The agency highlighted se…