Nipocalimab is a fully human, anti-FcRn, aglycosylated IgG1 monoclonal antibody that reduces pathogenic alloantibodies in maternal circulation and blocks the placental transfer of maternal IgG to the ...

The Food and Drug Administration (FDA) has granted Fast Track designation to nipocalimab (M281) for the prevention of hemolytic disease of the fetus and newborn (HDFN). The Food and Drug ...

Please provide your email address to receive an email when new articles are posted on . Alloimmunization rates were 6.2% for women matched to ABO and Rhesus D and 1.9% for women also matched for c, E ...

Please provide your email address to receive an email when new articles are posted on . Practice patterns vary widely for management of hemolytic disease of the fetus and newborn (HDFN). Researchers ...

Johnson & Johnson drug nipocalimab is in late-stage clinical testing in a rare neuromuscular disorder, and if it stays on track could become the third-to-market drug in its class for that indication.

Breakthrough Therapy Designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for HDFN Phase 3 clinical trial enrollment underway, representing the only therapy reported to ...

Nipocalimab delayed or prevented severe fetal anemia and 54 percent of study participants in the Phase 2 UNITY study achieved a live birth at or after 32 weeks without the need for intrauterine ...

"We are extremely proud to play a critical role in this clinical trial with the UNITY Fetal Antigen CTA test" said Oguzhan Atay, PhD, CEO of BillionToOne. "The ability to detect fetal antigens as ...