EU Accelerated Assessment Tracker
Rejections Mount In Q4
Global Blood Therapeutics' EU marketing application for Oxbryta (voxelotor) will undergo standard review once it is filed after the company failed to secure fast-track status for the sickle cell disease treatment. Only one product was granted accelerated assessment in October and November.
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A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
The latest drug development news and highlights from our US FDA Performance Tracker.
There is one orphan drug among the five new marketing authorization applications that the European Medicines Agency has under review. All five drugs will be reviewed under standard review timelines.