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Breakthrough therapy designtion

The Food and Drug Administration (FDA) has granted breakthrough therapy designation to GlaxoSmithKline (GSK) for its investigational B-cell mutation agent (BCMA) monoclonal antibody-drug conjugate, for relapsed and refractory multiple myeloma more

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Sanofi and Regeneron Pharmaceuticals have revealed that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation status to cemiplimab (REGN2810), an investigational human, monoclonal antibody. more

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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for 3,4-Methylenedioxymethamphetamine (MDMA) as a potential treatment (in combination with psychotherapy) for patients struggling with PTSD more

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The FDA has granted breakthrough therapy designation to Novartis’ investigational chimeric antigen receptor T cell (CAR-T) therapy, CTL019 more

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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Rhythm’s setmelanotide more

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CTL019, is the first personalised cellular therapy for the treatment of cancer to receive this important classification. more