FDA sets January decision for Pharming Group’s lower-dose Joenja pediatric expansion
FDA grants Priority Review to lower-dose Joenja for children with APDS weighing 13–27 kg, setting a January 30, 2027 decision date.
FDA grants Priority Review to lower-dose Joenja for children with APDS weighing 13–27 kg, setting a January 30, 2027 decision date.
Find out how Pharming’s Joenja sNDA resubmission could reopen the FDA pathway for younger children with APDS.