Aduhelm Gets Thumbs Down From EMA as Biogen Plans U.S. Confirmatory Study

In another huge blow to Biogen’s controversial Alzheimer’s blockbuster, the European Medicines Agency (EMA) has declined to approve Aduhelm (aducanumab), saying the data don’t support a strong clinical benefit and studies did not show that the medicine was sufficiently safe.
Source: Drug Industry Daily