The European Medicines Agency (EMA) reports that Gilead Sciences (GILD +0.6%) has submitted its marketing application seeking conditional approval of antiviral remdesivir for the treatment of COVID-19.
Considering that the regulator has already
reviewed quality and manufacturing data, preliminary results from
several clinical trial and supporting data from compassionate use
programs, the review timeline will be shortened and the advisory group
CHMP may issue an opinion “within weeks.” If positive, the EMA will work
closely with the European Commission to fast track a final decision.
Remdesivir is currently approved for emergency use
in the U.S. and Japan. The nod in Australia is imminent after a
taskforce backed approval last week.
https://seekingalpha.com/news/3581253-gilead-files-remdesivir-application-in-europe
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