FDA Accepts NDA for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma; PDUFA: May 2027 July 15, 2026
FDA approves SC Sarclisa (isatuximab-irfc) Escena + SOC for multiple myeloma patients across all existing indications of Sarclisa IV formulation July 15, 2026
CHMP recommendation advances TECVAYLI (teclistamab) plus daratumumab as a potential standard of care for RRMM June 30, 2026
Sarclisa SQ approved in the EU as the first anticancer treatment administered via an on-body injector June 17, 2026
FDA cleared CTA for LILRB4/CD3 targeting TCE bispecific antibody (6MW5311) for the treatment of AML, CMML, and Multiple Myeloma June 17, 2026
DARZALEX® (daratumumab) injectable approved for administration by patients or caregivers for treatment of multiple myeloma June 2, 2026
CellCentric Announces Oversubscribed $220 Million Series D Financing to Advance Pivotal Trials of Inobrodib in Multiple Myeloma May 12, 2026
Gilead Sciences Completes Acquisition of Arcellx Ahead of Potential Commercial Launch of Anito-cel May 6, 2026
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
