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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Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.