Pharming announces U.S. FDA acceptance and Priority Review of sNDA for lower doses of Joenja® to treat children with APDS
Pharming Group announced that the U.S. FDA has accepted for Priority Review its supplemental New Drug Application seeking approval for lower doses of Joenja® (leniolisib) to treat children aged 4 years and older weighing between 13 kg and 27 kg with activated phosphoinositide 3-kinase delta syndrome (APDS). The FDA's target action date is January 3…