Eisai initiates rolling submission for Leqembi autoinjector BLA to FDA
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 ... Read More
Biogen reprioritizes Alzheimer’s disease resources, discontinues ADUHELM development
Biogen Inc. (Nasdaq: BIIB), a leading pharmaceutical company, today announced a strategic reprioritization of its resources in Alzheimer’s disease (AD), a key therapeutic area expected ... Read More
Quanterix launches diagnostic test aiding early Alzheimer’s detection
Quanterix, a biomarker detection firm powering scientific research and breakthrough diagnostics, has introduced LucentAD, a new test designed to aid in the evaluation of patients ... Read More
Eisai, Biogen secure Leqembi FDA accelerated approval for Alzheimer’s disease
Eisai and Biogen have secured the approval of the US Food and Drug Administration (FDA) for their jointly developed Leqembi (lecanemab-irmb) under the accelerated approval ... Read More