Pharming Group N.V. announced that the U.S. FDA has accepted its resubmitted supplemental New Drug Application (sNDA) for Joenja® (leniolisib) to treat children aged 4 to 11 years with APDS. The resubmission seeks approval for 40 mg and 50 mg twice-daily dosing for pediatric patients weighing 27 kg or more, with a PDUFA target action date of October 24, 2026.
