EU Accelerated Assessment Tracker
Calliditas "Very Excited" By Success; Speedy Review Begins Of Takeda's Dengue Vaccine Candidate
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 aribavir and copanlisib respectively.
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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.
The European Medicines Agency today announced the new medicines it believes should be approved for use across the EU.
A number of advanced therapies are likely to be approved in the EU this year.