BioArctic AB’s partner Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector for weekly maintenance dosing. This follows the Fast Track designation granted by the FDA. In the U.S., Leqembi is indicated for the treatment of Alzheimer’s disease in […]
AgeneBio, a leading biopharmaceutical company specialising in central nervous system (CNS) disorders, has announced the enrolment of the first patient in its pivotal phase 3 clinical trial for AGB101, a promising treatment for amnestic Mild Cognitive Impairment (MCI) caused by Alzheimer’s Disease (AD). The trial, named HOPE4MCI, aims to assess the efficacy and safety of […]
