Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative ...
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The European Medicines Agency (EMA) recommended approval for 35 new therapeutic agents last year, compared with 27 in 2016 and 39 in 2015. The EMA's count includes small molecules, antibodies, ...
AstraZeneca Plc. AZN announced that the European Medicines Agency (EMA) has accepted a variation to the Marketing Authorisation Application (MAAv) for the label expansion of Tagrisso (osimertinib).
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