Regeneron (REGN) Gets CRL From FDA for Multiple Myeloma Drug
REGNRegeneron(REGN) ZACKS·2024-08-21 20:20

Regeneron Pharmaceuticals, Inc. (REGN) announced that it has received a complete response letter (CRL) from the FDA for its biologics license application (BLA) for pipeline candidate linvoseltamab.The BLA is seeking FDA approval of linvoseltamab for the treatment of relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies.Regeneron stated that the sole issue identified in the CRL is related to findings from a pre-approval inspection at a third-party fill/finis ...