In complete remission
FDA Issues Draft Guidance on MRD and CR Endpoints for Accelerated Multiple Myeloma Drug Approvals
FDA guidance; multiple myeloma; MRD; complete response; accelerated approval
Immunofoco Presents Phase I/IIa Data of IMC002 at ASCO GI 2026, Highlighting Durable Complete Response and 66.7% ORR in Advanced GC/GEJ
Immunofoco; IMC002; ASCO GI 2026; CAR-T; CLDN18.2; gastric cancer; complete response; ORR
FDA Rejects Biohaven’s Ataxia Drug Vyglxia, Forcing Company to Cut Costs After Second Approval Failure
Biohaven; FDA rejection; Vyglxia; troriluzole; spinocerebellar ataxia; CRL (Complete Response Letter); clinical trial design; external controls; drug approval; R&D cuts
Equillium’s pivotal GvHD study of anti-CD6 antibody comes up short
United States Food and Drug Administration, itolizumab, In complete remission, day, Equillium