Accelerated Assessment Success In EU For CSL Behring And Roche
EtranaDez Will Be And Mosunetuzumab Already Is On Fast-Track Review Pathway At EMA
Executive Summary
There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted.
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EU Accelerated Assessment Tracker
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Seventeen And Counting – Bumper Crop Of New EU Filings
Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.
Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa
Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year.