The U.S. Food and Drug Administration (FDA) has granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) ...
Halozyme Therapeutics announced its collaborator Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) ...
Halozyme Therapeutics announced its collaborator Janssen Biotech has received approval from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO™ (daratumumab hyaluronidase human- fihj).