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Johnson & Johnson’s Nipocalimab Earns Breakthrough Therapy Designation from FDA

Phase 3 clinical trial enrollment is underway.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Johnson & Johnson’s nipocalimab for the treatment of alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).   Nipocalimab is currently the only therapy reported to be in clinical development for the treatment of alloimmunized pregnant individuals at risk of severe HDFN, a serious and rare condition that occurs when the blood types of a pre...

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