Gilead Files For Remdesivir Approval In EU
A Decision Could Be Made In Weeks
The much-anticipated EU filing for Gilead’s COVID-19 treatment is being reviewed quickly by the European Medicines Agency.
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Gilead Sciences’ remdesivir could get the nod from the European Medicines Agency this week as a treatment for COVID-19, paving the way for swift EU approval.
The European Medicines Agency is anticipating greater use of its rolling review process during the coronavirus pandemic. Companies who use it will be asked to pay upfront half of what they would pay for a full marketing application.
In this latest update to coronavirus developments in the EU, the European Medicines Agency outlines plans to monitor demand for medicines in anticipation of a possible second wave of the COVID-19 pandemic later this year. It has also updated its adverse drug reaction literature monitoring service to cover potential coronavirus treatments, and backed the use of ACE-inhibitors and sartans during the pandemic.