Eisai and Biogen have completed their rolling biologics license application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi previously delayed by the FDA on ...

The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of ...

Leqembi — sold through a partnership between Eisai Co. and Cambridge-based Biogen — is one of the first medications approved ...

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal ...

Eisai/Biogen’s Leqembi (lecanemab) was fully approved in the US in July 2023, and Eli Lilly’s Kisunla (donanemab) in July ...

Biogen enhances its portfolio and margins amidst market challenges and competition. Click here to find out why BIIB stock is a Hold.

The specific tests necessary for patients to access Leqembi treatment have proved a thorn in Eisai and its U.S. commercialization partner Biogen since its 2023 launch. On the regulatory side ...

A key theme at the AD/PD 2025 has been the safety profile of DMTs, focusing on the issue of ARIA, a significant side effect ...

The European Union’s CHMP said that the benefits of the drug, already approved in the U.S., do not outweigh the risk of potentially fatal brain swelling and bleeding.

A global trade war, sparked by U.S. President Donald Trump, intensified earlier this month after he announced sweeping tariffs on most U.S. imports, stoking fears of a recession, sending jitters ...

Following the launch of the first disease-modifying therapies for Alzheimer’s disease, a key theme at the AD/PD 2025 ...