EU Accelerated Assessment Tracker
Executive Summary
Bayer has failed to convince the European Medicines Agency that its marketing authorization application for finerenone should be fast-tracked through the EU's centralized review process. There were other successes, though, although Janssen is keeping us guessing over its MAA for amivantamab. These and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
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EU Accelerated Assessment Tracker
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.