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Genetic and Congenital

FDA accepts priority review for leniolisib for treatment of APDS

The U.S. Food and Drug Administration has accepted for priority review a New Drug Application (NDA) for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older in the...

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