FX.co ★ FDA Issues Complete Response Letter For Regeneron's Linvoseltamab In R/R Multiple Myeloma

Regeneron Pharmaceuticals Inc. (REGN) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab, intended for the treatment of relapsed/refractory multiple myeloma that has progressed following at least three prior therapies.

The company noted that the only issue affecting the approval is connected to findings from a pre-approval inspection at a third-party fill/finish manufacturer, which pertains to another company's product candidate.