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.
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A number of advanced therapies are likely to be approved in the EU this year.
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.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.