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Johnson & Johnson s nipocalimab granted U S FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)

/PRNewswire/ Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for.

United statesPrnewswire johnsonBridget kimmelKatie abouzahrDrug administrationExchange commissionHematology am soc hematol educ programJanssen research developmentJanssen biotech incNone of the janssen pharmaceutical companiesNational library of medicineJanssen pharmaceutical companiesFetal medicine foundation world congressBreakthrough therapy designationVice presidentMaternal fetal immunology disease area leader

New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

/PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from the proof-of-concept Phase 2 open-label UNITY.

United statesOhio state universitySpring houseBritish columbiaMemorial hermann hospitalKatie shanahanMoise kj jrKatie abouzahrKennethj moise jrBridget kimmelKenneth moiseJanssen pharmaceutical companies of johnsonDrug administrationFetal medicine foundation world congressJanssen pharmaceutical companiesAllo hope foundation

Nipocalimab Benefits Mechanism of HDFN in Phase 2 Trial

Janssen reported significant benefit, and a tolerable profile, for the investigative drug that may become the first indicated to treat HDFN.

Katie abouzahrDrug administrationJanssen pharmaceutical companies of johnsonEuropean medicines agencyJanssen research developmentFetal medicine foundation world congressPharmaceutical companiesJanssen researchFast track

New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Haemolytic Disease of the Foetus and Newborn (HDFN)

New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Haemolytic Disease of the Foetus and Newborn (HDFN)
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United statesOhio state universityMemorial hermann hospitalRegion flamandeKennethj moise jrKenneth moiseKatie abouzahrMoise kj jrHematology am soc hematol educ programFetal medicine foundation world congressEuropean unionNone of the janssen pharmaceutical companiesJanssen pharmaceutical companies of johnsonDrug administrationDepartment of women healthExchange commission