Regeneron's linvoseltamab CRL from FDA for multiple myeloma treatment due to third-party fill/finish manufacturer issue.
Regeneron's blood cancer therapy, linvoseltamab, received a CRL from the US FDA for relapsed/refractory multiple myeloma treatment. The sole approvability issue concerns pre-approval inspection findings at a third-party fill/finish manufacturer. Regeneron and the FDA are collaborating to address it, while the therapy remains under EU review.
August 20, 2024
15 Articles