Janssen seeks EMA’s expanded approval for DARZALEX in AL amyloidosis

Janssen seeks EMA’s expanded approval for DARZALEX in AL amyloidosis

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) seeking the expanded approval for DARZALEX (daratumumab) in subcutaneous (SC) formulation to include the treatment of patients having light chain (AL) amyloidosis. Considered as a rare and potentially fatal disease, AL amyloidosis is due […]

Janssen, Amgen secure FDA approval for DKd regiment in multiple myeloma

Janssen, Amgen secure FDA approval for DKd regiment in multiple myeloma

DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have been granted an expanded approval from the US Food and Drug Administration (FDA) for the DKd regimen comprising the former’s DARZALEX (daratumumab) and the latter’s Kyprolis (carfilzomib) plus dexamethasone for the treatment of multiple myeloma. The approval […]