Rh disease

Rallybio Presents Natural History Study for Fetal and Neonatal Alloimmune Thrombocytopenia at the 65th American Society of Hematology Annual Meeting

Retrieved on: 
Saturday, December 9, 2023
Science, Biotechnology, Research, Health, Baby, Maternity, Consumer, Clinical Trials, Other Health, Neonatal alloimmune thrombocytopenia, Woman, Weill Cornell Medicine, ASH, Pregnancy, Risk, Disease, Corporation, Hospital, Patient, Rh disease, Mother, Society, RH

The FNAIT natural history study is a prospective, non-interventional, multinational alloimmunization study to determine the frequency of expectant mothers of diverse races and ethnicities at higher FNAIT risk.

Key Points: 
  • The FNAIT natural history study is a prospective, non-interventional, multinational alloimmunization study to determine the frequency of expectant mothers of diverse races and ethnicities at higher FNAIT risk.
  • This FNAIT natural history study is the first prospective study that seeks to characterize risk for FNAIT in a racially and ethnically diverse population of pregnant women.
  • Rallybio expects to screen up to 30,000 expectant mothers in the natural history study, with an estimated 7,600 women screened by the end of 2023.
  • Data from the natural history study is designed to provide a contemporary control for the planned single-arm Phase 3 registrational study.

Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Nipocalimab in HDFN

Retrieved on: 
Tuesday, July 28, 2020
Medical specialties, Blood, Transfusion medicine, Hematology, Acquired hemolytic anemia, Hemolytic disease of the newborn, Infant mortality, Food and Drug Administration, Hemolysis, Rh disease

CAMBRIDGE, Mass., July 28, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) today 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).

Key Points: 
  • CAMBRIDGE, Mass., July 28, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) today 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).
  • Rare pediatric disease designation is granted by the FDA to drug candidates addressing serious or life-threatening diseases or conditions that affect fewer than 200,000 children in the U.S.
  • For more information about the rare pediatric disease program, please visit the FDA website at www.fda.gov .
  • Hemolytic disease of the fetus and newborn (HDFN) is a rare alloimmune disorder affecting pregnant women and their families.