A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...

Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...

Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.

If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer's medicine available in the ...

Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be ...

Bristol Myers Squibb (BMY) has received a recommendation for approval from an expert panel of the European Medicines Agency ...

InflaRx (IFRX) has released an update. InflaRx has received a positive opinion from the European Medicines Agency’s CHMP for GOHIBIC, a ...

A new study reveals that more than half of cancer drugs approved by the FDA under accelerated pathways are not authorized in ...

Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...

CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three ...

Afqlir® (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration ...

The EMA sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.