Regeneron Pharmaceuticals Inc. (REGN) said that the U.S. Food and Drug Administration has issued a Complete Response Letter or CRL for the Biologics License Application or BLA for linvoseltamab in relapsed/refractory multiple myeloma that has progressed after at least three prior therapies.
According to the company, the sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company's product candidate.
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