SK Bioscience Pulls EU Filing For COVID Jab As Regulators Shift Focus To XBB Vaccines

The European Medicines Agency’s CHMP was set to adopt opinions on SK Bioscience’s COVID-19 vaccine and Mycovia/Gedeon’s Vivjoa for vulvovaginal candidiasis during its September meeting, but both marketing authorization filings were voluntarily withdrawn.

Withdrawn Stamp
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South Korea’s SK Bioscience voluntarily withdrew its EU conditional marketing authorization application (MAA) for SKYCovion/GBP510, a recombinant COVID-19 vaccine, on 1 September, ahead of this week’s meeting of the European Medicines Agency’s human medicines committee, the CHMP.

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