FDA Decision Delay Puts GSK’s Blenrep Comeback on Hold Amid Safety Concerns
SHERIDAN, WYOMING – July 25, 2025 – The U.S. Food and Drug Administration has delayed its decision on GSK’s antibody-drug conjugate Blenrep, postponing the company's market reentry plans for the treatment of relapsed or refractory multiple myeloma. The updated Prescription Drug User Fee Act (PDUFA) target date is now set for October 23, 2025, following the agency's request for additional information.