The U.S. Food and Drug Administration released draft guidance describing how measurable residual disease (MRD) negativity and complete response rates may be used to support accelerated approvals in multiple myeloma. The guidance outlines evidentiary expectations, trial design considerations, and assay validation criteria for sponsors seeking near‑term regulatory pathways based on molecular endpoints. BioCentury reported the draft, which industry players welcomed as a step toward biomarker‑driven endpoints for hematologic oncology. Regulators framed the guidance as intended to spur innovation while emphasizing the need for robust assay standardization and post‑approval confirmatory trials. The guidance creates a clearer framework for companies developing MRD‑targeted therapies to engage earlier with FDA.