The FDA on November 19, 2025, granted traditional approval to DARZALEX FASPRO® with Bortezomib, Cyclophosphamide, and Dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021. DARZALEX FASPRO® is a product of Janssen Biotech Inc.
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