Keeping Track: US FDA Clears Bylvay, Fexinidazole, Gives Retifanlimab CRL; JAK Inhibitor Class Delays

The FDA issued decisions on three novel agents in this past week, all for orphan diseases. Two of the products were approved: Albireo Pharma Inc.’s Bylvay and Sanofi and the Drugs for Neglected Diseases Initiative’s fexinidazole. The third, Incyte Corporation’s retifanlimab, went home with a complete response letter.