This article was originally published in RAJ Devices
EU legislative recast reprieve
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Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.
If Zolgensma gets the thumbs up from the EMA this week, it will likely get formal EU approval within a couple of months.
BMS should find out mid-2020 whether its new MS drug will be approved in the EU.