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EMA Approves CAR-T Therapy Manufactured by AGC Biologics

Marks the 10th product approval for AGC Biologics’ Milan site.

The European Commission recently approved AUCATZYL (obecabtagene autoleucel – obe-cel), marking the 10th product approval for AGC Biologics’ Milan site from the EMA or the U.S. FDA. Developed by Autolus Therapeutics, AUCATZYL is approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This follows prior authorizations from the FDA in November 2024 and the U.K. MHRA in April 2025. “This European approval for Autolus is a milestone we a...

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