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

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

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.

Novartis AG stood out on the submissions front, with news of the breakthrough-designed oncologic asciminib and the return of inclisiran after an unexpected complete response letter

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