The U.S. Food and Drug Administration has accepted Bristol Myers Squibb's New Drug Application for iberdomide in combination with standard treatment for patients with relapsed or refractory multiple myeloma. The application is being reviewed under the FDA's Project Orbis initiative, which allows concurrent review by health authorities in several countries. Iberdomide has been granted Breakthrough Therapy Designation and Priority Review, with a target action date of August 17, 2026. The submission is based on data from the Phase 3 EXCALIBER-RRMM study.

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