EU Accelerated Assessment Tracker
Bayer and Takeda Fail In Quest For Fast-Track Review
EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency.
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The sponsors of four drugs were due or possibly due to appear before the European Medicines Agency to explain why their respective products merit EU-wide approval.
Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.
EU reviewers will decide this week whether to grant accelerated assessment to a handful of new dug candidates that will soon be filed for approval.