FDA extends review period for Sarclisa (isatuximab-irfc) SC BLA by up to 3 months; new target action date July 23, 2026 April 28, 2026
Blenrep (belantamab mafodotin) approved in China for treatment of 2L+ relapsed/refractory multiple myeloma April 21, 2026
First Patient Dosed in Ph 1b Trial of Cemsidomide in Combination with Elranatamab (ELREXFIO) for Relapsed/Refractory Multiple Myeloma March 31, 2026
Japan’s PMDA approves Initiation of Clinical Trial for CAR-T Therapy Equecabtagene Autoleucel in 2L/3L Multiple Myeloma March 31, 2026
Positive Ph 3 Results from SUCCESSOR-2 Study of Oral Mezigdomide in Relapsed or Refractory Multiple Myeloma Announced March 10, 2026
First Patient Dosed in Ph 2 MOMENTUM Trial of Cemsidomide in Combination with Dexamethasone for Relapsed/Refractory Multiple Myeloma March 3, 2026
FDA grants Breakthrough Therapy Designation, Priority review and accepts NDA for Iberdomide in RRMM Patients; PDUFA Aug 2026 February 25, 2026
IBI3003 Receives FDA Fast Track Designation for Relapsed or Refractory Multiple Myeloma February 1, 2026
DARZALEX FASPRO®-based quadruplet regimen approved in the US for 1L transplant-ineligible multiple myeloma patients February 1, 2026
FDA sets draft rules for using MRD for supporting accelerated approvals in multiple myeloma January 25, 2026
TECVAYLI monotherapy demonstrates superior PFS and OS vs SOC in patients with R/R multiple myeloma January 18, 2026
TECVAYLI® plus DARZALEX FASPRO® combination selected for Commissioner’s National Priority Voucher Pilot program December 22, 2025
BLA Approval of Fucaso (Equecabtagene Autoleucel) by the Hong Kong Department of Health for the Treatment of R/R Multiple Myeloma Announced December 2, 2025
DARZALEX FASPRO® approved by FDA for patients with high-risk smoldering multiple myeloma November 10, 2025
