EU Accelerated Assessment – Hard To Get, Hard To Keep
It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.
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If Zolgensma gets the thumbs up from the EMA this week, it will likely get formal EU approval within a couple of months.
The EU marketing application for cefiderocol that lost fast track status last July is now up for an opinion by the European Medicines Agency.
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.