EU Accelerated Assessment Tracker
Novartis Fails To Secure Fast-Track Review For Trabecta
Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin.
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BioMarin plans to file for approval of its investigational hemophilia A gene therapy in the EU in June this year but its US filing is not planned until Q2 2022. It will be the company's second attempt at success in both jurisdictions.
The European Medicines Agency today revealed the names of the latest new products it believes should be approved for use across the EU.
The EU is set to be the first market to approve bluebird bio’s one-time gene therapy for cerebral adrenoleukodystrophy.