Dengue Vaccine Qdenga & Nine Drugs Win EMA Thumbs Up
Executive Summary
The European Medicines Agency has delivered its verdict on marketing applications for a raft of new medicines.
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EU CHMP Opinions And MAA Updates
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 EU, and updates on EU marketing authorization changes recommended by the CHMP.
EU CHMP Opinions And MAA Updates
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 EU, and updates on EU marketing authorization changes recommended by the CHMP.
Takeda Pulls US BLA For Dengue Vaccine
Despite a priority review being granted late last year by the FDA, Takeda has announced the surprise withdrawal of the US BLA for its dengue vaccine TAK-003, for reasons it said centered on "data collection" issues. The quadrivalent vaccine has already been approved as Qdenga in several other markets including the EU, Indonesia and Thailand and the future path in the US is currently uncertain.