EU Accelerated Assessment Tracker
Calliditas "Very Excited" By Success; Speedy Review Begins Of Takeda's Dengue Vaccine Candidate
Executive Summary
Calliditas Therapeutics' lead product candidate Nefecon will be fast-tracked at the EMA once the marketing application is filed. Takeda and Bayer are hoping for the same success with maribavir and copanlisib respectively.
You may also be interested in...
AZ/Amgen Fail In EU Fast-Track Bid For Tezepelumab
European drug reviewers are not convinced that AstraZeneca and Amgen's investigational treatment for severe asthma, tezepelumab, should be fast-tracked through the EU evaluation system once the companies file for approval.
EMA Says Yes To Eight New Medicines, Holds Fire On Others
The European Medicines Agency today announced the new medicines it believes should be approved for use across the EU.
EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.