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Latest From Maureen Kenny
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.
The European Medicines Agency says that Shionogi’s novel antibiotic, Fetcroja, should be approved for use across Europe but that Lilly's migraine drug, Emgality, should not be authorized for the extended indication of episodic cluster headache.
EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.
Vertex is hoping for EU approval in Q4 of its cystic fibrosis triple combination therapy, Trikafta. It wants the same licence in the EU as it has in the US, where the product has already become a best seller for the company.