Regulatory News


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Tecartus Recommended for EU Approval as CAR T-cell Therapy for Mantle Cell Lymph...

A committee of the European Medicines Agency (EMA) has recommended the conditional approval of Tecartus (brexucabtagene autoleucel) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).

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Guidance Documents CBER is Planning to Publish During Calendar Year 2020

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Assessing Immunogenicity of Products for Gene Therapy and T cell Therapy

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Cellular & Gene Therapy Products

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Qualification opinion on Cellular therapy module of the European Society for Blo...

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First two CAR-T cell medicines recommended for approval in the European Union

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