Biogen Inc. shares climbed 1.7% on Monday afternoon, reaching a nearly two-week high, as positive regulatory news countered ...

Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...

With this approval, patients who receive the anti-amyloid drug biweekly for 18 months can then consider switching to a monthly dosing regimen.

The FDA has accepted Alvotech (ALVO) and Teva's (TEVA) applications for AVT05, their proposed biosimilar to J&J's ...

The U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, ...

This SPA agreement marks an important milestone in the development of Descartes-08 for MG, providing critical regulatory clarity and a clear path toward potential approval,” said Carsten Brunn, Ph.D., ...

Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...

The share price of Atara Biotherapeutics Inc. began a slow climb up after the company experienced a steep drop earlier this month. The Thousand Oaks drug ...

Japan’s Nippon Shinyaku is continuing to scoop up the international rights to some intriguing drugs, this time penning a $686 ...

Riding recent momentum in the Duchenne muscular dystrophy space, Capricor Therapeutics, Wave Life Sciences, Regenxbio and ...

The Japanese pharma had one asset rejected by the FDA and withdrew a regulatory application for another, but already this ...