March 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
Based on findings from the phase 3 MajesTEC-3 trial, the FDA announced the approval of teclistamab (Tecvayli) plus daratumumab hyaluronidase-fihj for adults with relapsed or refractory multiple myeloma who...
The FDA approval expands frontline treatment options for adults with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant, based on randomized trial data showing...
A pooled analysis of 4 MagnetisMM trials evaluated dosing strategies for elranatamab, a BCMA-CD3 bispecific antibody, to identify the optimal regimen that mitigates cytokine release syndrome in patients...
An open-label, randomized trial found that daratumumab and hyaluronidase-fihj administered subcutaneously improved the risk of disease progression or death in patients with multiple myeloma. As a result,...
A phase 2 trial from the University of Miami evaluated whether combining iberdomide with carfilzomib, daratumumab, and dexamethasone could induce deep responses—including MRD-negativity—in patients with...
A randomized phase III study evaluated whether a carfilzomib-based triplet regimen could improve depth of response and progression-free survival compared with standard bortezomib-based therapy in patients...
A new real-world study evaluates whether GLP-1 receptor agonists, commonly prescribed for diabetes and obesity, are associated with a reduced risk of progression from monoclonal gammopathy of undetermined...
In a multicenter US study of patients with relapsed/refractory multiple myeloma receiving commercial ciltacabtagene autoleucel, investigators examined whether rapid peak CAR T-cell expansion and absolute...
A phase 1b–2 trial published in The New England Journal of Medicine evaluated the combination of two bispecific antibodies, talquetamab and teclistamab, for patients with relapsed or refractory multiple...
