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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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.
The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.