Two Hopefuls And A ‘No’: EMA Decisions On Accelerated Access
Executive Summary
Regeneron and Shire should find out this week whether the European Medicines Agency will agree to fast-track its review of their products.
You may also be interested in...
Dova Keeps Mum On EU Fast-Track Request Outcome; Requests Well Down
There has been a sharp fall in the number of companies seeking accelerated assessment for their investigational products at the European Medicines Agency. One such company that has asked – Dova Pharmaceuticals – is staying silent on the outcome of its request.
New EMA Filings: Speedy Review For Lanadelumab But Cemiplimab Gets Standard Treatment
Shire and Regeneron/Sanofi are among the companies that have recently submitted investigational new treatments for approval across the EU.
Dova Aims For Accelerated Assessment In EU For Avatrombopag
Will the European Medicines Agency decide this week that Dova Pharmaceuticals’ eventual marketing authorization application for avatrombopag should be fast-tracked? If it does, the potential new thrombocytopenia therapy would join just a handful of products that are being reviewed under the EMA’s accelerated assessment pathway.