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Latest From Maureen Kenny
Roche has secured accelerated assessment at the European Medicines Agency for its new immunosuppressant, satralizumab. The outcomes of five other fast-track requests that companies have made for their planned marketing authorization applications are still unknown.
New medicines under evaluation at the European Medicines Agency.
There are six new entries on the latest list of products under review at the European Medicines Agency – products with orphan status from Roche and Novo Nordisk and four generic or biosimilars.
The outcomes of six requests for accelerated assessment that companies have made for their planned marketing authorization applications in the EU are still unknown.
Just two products are being assessed under the EMA's fast-track mechanism now that the marketing application for Roche's Polivy has reverted to standard review.