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Albireo Pharma Inc.

https://www.albireopharma.com/

Latest From Albireo Pharma Inc.

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

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

US FDA Performance Tracker Approvals

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.

Rare Diseases Approvals

10 US Approval Decisions To Look Out For In Q3

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

Approvals Companies

EU Accelerated Assessment Tracker

Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin. 

Europe European Performance Tracker
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Albireo AB
    • Biodel Inc.
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