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Keeping Track: Oxbryta Approval Headlines Pre-Thanksgiving Week Of News

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker.

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Five New EU Filings Leave Starting Blocks at EMA

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.

Rejection Rate Soars In Q4 For EU Fast-Track Requests

October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.

EU Accelerated Assessment Tracker

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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