Novartis And Stemline Try For Fast-Track EU Review

The European Medicines Agency is this week deciding whether it will fast track its review of orphan drugs that Novartis is developing for the treatment of Cushing's syndrome and Stemline Therapeutics is developing for the hematologic malignancy, BPDCN.

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Requests for fast track drug reviews in the EU are being considered this week • Source: Shutterstock

Novartis and Stemline Therapeutics will likely learn this week whether the EU marketing applications they plan to file for their investigational treatments for Cushing's syndrome and blastic plasmacytoid dendritic cell neoplasm (BPDCN) respectively will be granted fast-track review.

The companies’ requests for regulatory review via the European Medicines Agency’s accelerated assessment procedure are due to be considered by...

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