News about "DARZALEX FASPRO"

FDA Approves DARZALEX Faspro for Adult Patients with High-Risk Smoldering Multiple Myeloma

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

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

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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