SPL84-23 for CF Splicing mutation named orphan drug in the USA, EuropeBoth the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted orphan drug status to SPL84-23, SpliSenseҳ..#Cystic Fibrosis·disorders.solutions·Jan 10, 2022SPL84-23 for CF Splicing mutation named orphan drug in the USA, Europe