FDA issues a CRL for linvoseltamab’s BLA in R/R multiple myeloma that has progressed after at least three prior therapies

“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. The third-party fill/finish manufacturer has since informed Regeneron that it believes the findings have been resolved, their facility is awaiting reinspection by the FDA, and it is expected to take place in the coming months.”

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