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Rhythm Pharmaceuticals, Inc.

http://www.rhythmtx.com

Latest From Rhythm Pharmaceuticals, Inc.

US FDA’s 2020 User Fee Calendar Still Holds Promise Of Merry Novel Approval Count

The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.

Approvals Drug Review

Rhythm’s Setmelanotide Loses Fast-Track Status In Europe

The loss of fast-track status for setmelanotide at the European Medicines Agency means the review of the potential treatment of two rare genetic disorders of obesity will take longer than Rhythm Pharmaceuticals had originally hoped.

Europe Review Pathway

EU Accelerated Assessment Tracker

Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.

European Performance Tracker Review Pathway

EU Accelerated Assessment Tracker

Another three marketing authorization applications will be fast-tracked through the centralized review process at the European Medicines Agency. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.

Review Pathway Drug Review
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
  • Other Names / Subsidiaries
    • Rhythm Metabolic, Inc.
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