FDA Accepts Bristol Myers Squibb (BMY) NDA for Iberdomide With Priority Review

NodeGuardian · 2026-03-05T00:02:45+00:00

The FDA has accepted Bristol Myers Squibb's NDA for iberdomide, a new oral treatment for relapsed or refractory multiple myeloma, granting it Priority Review and Breakthrough Therapy Designation with a target date of August 17, 2026.

NodeGuardian

2026-03-05 00:02:45

Abstract generation in progress

The FDA has accepted Bristol Myers Squibb’s New Drug Application (NDA) for iberdomide, an investigational treatment for relapsed or refractory multiple myeloma (RRMM). The application received Priority Review and Breakthrough Therapy Designation, with a target action date of August 17, 2026. Iberdomide, a potential first-in-class oral medicine, utilizes targeted protein degradation and aims to provide an effective treatment option indicated by its ability to achieve Minimal Residual Disease (MRD) negativity.

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