Resubmission of the supplemental biologics license application provided more data on improvement in hives and itching in ...

Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi ...

The European Commission on Tuesday authorized the use of Eisai and Biogen's drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than ...

Leqembi gains European approval after CHMP reversal, despite safety concerns tied to brain swelling and bleeding in Alzheimer ...

Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's radiopharmaceutical sector, according to the European Medicines Agency (EMA). Vi ...

Cullinan Therapeutics (CGEM) announced that the European Medicines Agency, EMA, approved the Company’s Clinical Trial Application, CTA, for ...

CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.

EMA orphan drug designation is awarded to drugs intended to treat rare diseases that are life-threatening or chronically debilitating < ...

Anavex could secure conditional approval for blarcamesine, though longer trials may be needed. Check out why AVXL stock is a ...