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.
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Attempts by companies to have their investigational products fast-tracked through the EU approval system this year so far have largely failed. Often the same products have or had priority review in the US. With the European Medicines Agency deciding on four new accelerated assessment requests this week, will the tide start to turn?
J&J is hoping its experimental new drug for treatment-resistant depression will join the select group of products benefitting from speedy review in the EU.
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.