Regulatory News


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The EMA Review of Belantamab Mafodotin (Blenrep) for the Treatment of Adult Pati...

  Nov 11 2020 Tagged mAbs, MM

This is the first monoclonal antibody to target this antigen in multiple myeloma, which represents a true novelty from a pharmacological point of view.

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Evolving use of real-world evidence in the regulatory process: a focus on immuno...

This article reviews current literature on the use of RWE for regulatory submissions, with a focus on novel anticancer immunotherapies, and discusses the utility and current limitations of RWE in the context of drug development and regulatory approvals.

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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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