China is not as big a player in the manufacturing of key ingredients used to make brand and generic medicines as previously ...

Leqembi approved by the EU for early-stage Alzheimer’s in patients with specific ApoE4 gene profile, marking a milestone in ...

The antiviral drug tecovirimat (Tpoxx) didn't accelerate lesion clearance in adults and children with clade 1 mpox ...

The trial will assess the therapy’s pharmacokinetics, pharmacodynamics and safety, as well as its impact on disease activity.

With the acquisition of Theravia, Norgine will now have six core products in its rare disease portfolio (PEDMARQSI ®, eflornithine, mavorixafor, AGILUS ®, SIKLOS ® and ORPHACOL ®) thereby comprising a ...

The European Commission said Wednesday that it had given formal approval for Leqembi, a long-awaited new treatment for ...

Following the nod in the EU, BIIB & Eisai's Leqembi becomes the first therapy to slow the progression of early Alzheimer's ...

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

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

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

Eisai Europe Ltd. and Biogen Inc. announced today that the European Commission (EC) has granted Leqembi® (lecanemab) Marketing Authorisation (MA) in the European Union (EU).1 This makes the medicine ...

The antibody lecanemab is the first authorized therapy in Europe that targets the underlying process of Alzheimer's, rather than only treating symptoms.