Johnson & Johnson

NYSE:JNJUnited States

Ratings actions from Benzinga: https://www.benzinga.com/quote/JNJ/analyst-ratings

(END) Dow Jones Newswires

November 15, 2024 05:39 ET (10:39 GMT)

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:
-- U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 -- U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023 -- U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024 -- EU EMA Orphan medicinal product designation for HDFN in October 2019