FDA Approves DARZALEX Faspro for Adult Patients with High-Risk Smoldering Multiple Myeloma
The US FDA has approved DARZALEX Faspro as the first treatment for adult patients with High-Risk Smoldering Multiple Myeloma (HR-SMM), marking a key milestone in addressing this early stage of the disease.
DARZALEX Faspro | 11/11/2025 | By Dineshwori
European Commission Approves DARZALEX Faspro for Adults with Smouldering Multiple Myeloma
Halozyme Therapeutics has announced European Commission approval for DARZALEX Faspro, co-formulated with ENHANZE, as a monotherapy for high-risk smouldering multiple myeloma in adults, marking a shift from passive monitoring to early intervention.
DARZALEX Faspro | 24/07/2025 | By Mrinmoy Dey | 132
Johnson & Johnson Submits sBLA to FDA for Approval of DARZALEX FASPRO-Based Quadruplet Regimen
The CEPHEUS study evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone (VRd) for NDMM patients for whom ASCT was not planned as initial therapy.
DARZALEX FASPRO | 01/10/2024 | By Aishwarya | 240
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