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- 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…
- FDA approves Orca Bio's T cell therapy Tregzi to lower transplant complications in blood cancer patientsThe U.S. Food and Drug Administration has granted approval to Orca Bio's T cell therapy aimed at improving outcomes for patients undergoing blood cancer transplants. The therapy, named Tregzi, is…