The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
Research supporting the amyloid hypothesis—the idea that Alzheimer's is caused by a buildup of amyloid plaques in the ...
The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.
Children who inherit genetic mutations from parents with early-onset Alzheimer’s typically show signs of dementia at the same ...
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Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's ...
The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...
BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved ...
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...