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

Executive Summary

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

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Mobocertinib, Asciminib & Surufatinib Among Latest New Filings In EU

The European Medicines Agency has added nine new products to its latest list of medicines that are under review for potential EU marketing authorization.

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ICER discussion on the health benefit of several upcoming drugs for atopic dermatitis, including several JAK inhibitors, touches on safety concerns and the likelihood that increased competition will open the door to higher list prices and rebating in the class.

Albireo Dashes Into PFIC Market As FDA, EMA Approve Bylvay

The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.

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