multiple myeloma

The US FDA has granted 510(k) clearance for the Hydrashift 2/4 daratumumab assay from Sebia, which is intended for use with Hydragel IF for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. more


The US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics licence application (sBLA) for the use of daratumumab in front line multiple myeloma. more