The U.S. FDA released draft guidance endorsing measurable residual disease (MRD) negativity and complete response as potential accelerated approval endpoints for multiple myeloma, signaling a regulatory pathway to shorten development timelines for cell, gene and other therapies. The draft follows an ODAC recommendation and industry letters from major developers including J&J that backed MRD use under defined circumstances. Agency materials and BioCentury analysis emphasize conditions for assay validation and post‑approval confirmatory data to support full approval. What happened: FDA formalized draft criteria for using MRD and CR as near‑term efficacy measures in multiple myeloma, which could materially speed trials and investment decisions. Sources: FDA draft guidance and BioCentury reporting. Technical note: MRD assays require validated sensitivity and standardized reporting to be used as primary endpoints.