Indication-level milestones
Follow approvals, labels, European status, and supply
Separate source views cover FDA oncology actions, DailyMed label versions, EMA medicine status, and current FDA shortage records.
Reviewed DailyMed SPL records
Myeloma-indicated records
Current FDA shortage entries
Indication and regimen actionsSelected FDA oncology notifications; FDA does not announce every approval or label update here.
Aug 13, 2026
Accelerated approvalCD38 / Cereblon / Glucocorticoid receptor
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
Daratumumab + Iberdomide + DexamethasoneFDA source
Jul 9, 2026
ApprovalCD38
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.
IsatuximabFDA source
Mar 5, 2026
ApprovalBCMA × CD3 / CD38
FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
Daratumumab + TeclistamabFDA source
Jan 27, 2026
ApprovalCD38 / Cereblon / Glucocorticoid receptor / Proteasome
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
Daratumumab + Lenalidomide + Bortezomib + DexamethasoneFDA source
DailyMed labels are matched through a reviewed therapy list. EMA records require multiple myeloma in the therapeutic indication or plasma cell myeloma in the therapeutic area. FDA shortage records are limited to current oncology records matching reviewed therapy aliases; availability is presentation-specific.