The U.S. Food and Drug Administration released a draft guidance clarifying that measurable residual disease (MRD) negativity and complete response could support accelerated approval pathways in multiple myeloma. The agency outlined circumstances where MRD, measured with validated assays, may serve as a primary or surrogate endpoint to shorten pivotal timelines for certain therapies. Separately, the FDA issued broader commentary on new multiple myeloma endpoints and stakeholder implications. Biotech and pharma firms developing cell therapies and targeted myeloma agents said the guidance could materially accelerate late‑stage programs, though sponsors will need to demonstrate assay standardization, clinical meaningfulness and robust MRD‑outcome correlations.