EU Aduhelm Filing: Biogen Faces Second High-Stakes Meeting At EMA
Biogen needs to explain why its Alzheimer’s disease drug should be approved in the EU, after the European Medicines Agency rejected the product last year.
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The marketing application was withdrawn before the European Medicines Agency had finished re-examining its earlier recommendation to reject the drug.
A first-of-its-kind drug for uterine fibroids and a new monoclonal antibody treatment for COVID-19 are among several new drugs recommended for pan-EU approval this month.
The sponsors of aducanumab and three other drugs are set to explain why their EU marketing authorization applications merit approval during oral explanation meetings at the European Medicines Agency.