WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) Tuesday said that the resubmission of Biologics License Application (BLA) for linvoseltamab for the treatment of multiple myeloma has been accepted by the U.S. FDA.
A decision from the regulator is expected on July 10, 2025.
The BLA acceptance follows resolution of third-party fill/finish manufacturing issues identified by the FDA in the previous submission.
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