Following a rolling review that kicked off in late April, the EMA this week recommended conditionally authorizing Gilead Sciences’ remdesivir to treat patients ages 12 and older with severe coronavirus disease (COVID-19) requiring supplemental oxygen. The EMA says it expects the European Commission to sign off on the conditional marketing authorization for remdesivir next week using a fast-track process, which will allow the drug to be marketed across the EU. As part of the conditional marketing authorization, the EMA says Gilead will have to submit final study reports for remdesivir by December 2020 and additional data on quality and final mortality data by August 2020. Learn More