Timelines
Notable FDA Approvals
Timelines
07/27/2026
July 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,...
07/27/2026
FDA Approval
FDA Approval
07/23/2026
Anthony Calabro, MA
The FDA approved subcutaneous isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis US LLC) for multiple myeloma treatment regimens across relapsed, refractory, and newly diagnosed disease settings.
07/23/2026
Timeline Snapshot
physicians looking at ipad
Timeline Snapshot
04/16/2026
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,...
04/16/2026
FDA Alert
FDA Alert
03/06/2026
Kate Young
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...
03/06/2026
FDA Alert
FDA Alert
02/05/2026
Anthony Calabro, MA
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...
02/05/2026
research summary
research summary
12/22/2025
Anthony Calabro, MA
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...
12/22/2025
FDA Alert
FDA Alert
12/15/2025
Kate Young
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,...
12/15/2025
Conference Coverage
Conference Coverage
12/09/2025
Kate Young
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...
12/09/2025
Conference Coverage
Conference Coverage
12/08/2025
Anthony Calabro, MA
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...
12/08/2025
Conference Coverage
Conference Coverage
12/06/2025
Ashton L. Stahl
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...
12/06/2025