Posted by Michael Wonder on 08 Jun 2021
Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease
8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug application for ruxolitinib (Jakafi) for the treatment of adult and paediatric patients 12 years and older with steroid refractory chronic graft versus host disease.
The new Prescription Drug User Fee Act target action date is 22 September 2021.
