Momenta Pharmaceuticals, Inc. announced that its novel drug candidate, nipocalimab, has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the prevention of hemolytic disease of the fetus and newborn (HDFN). Additionally, FDA granted nipocalimab orphan drug designation in HDFN. HDFN is a serious blood disorder in a fetus or newborn that occurs when red blood cell incompatibility exists between the blood types of a mother and fetus in utero. The standard treatment for HDFN involves intrauterine blood transfusions which are invasive and can be associated with significant complications, including in some cases fetal mortality. Receiving this designation emphasizes the need for a non-invasive, safe, and effective treatment option.