Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...
In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...
The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...
Biogen and Eisai have hit another bump in their quest to win European regulatory approval of their Alzheimer's drug Leqembi. The companies on Friday said the European Commission has asked the ...
The FDA's approval is based on simulation data from multiple studies showing that maintenance dosing with Biogen???s Leqembi ...
Biogen Inc. (NASDAQ:BIIB), a leading biopharmaceutical company specializing in neurology and rare diseases, finds itself at a critical juncture as it navigates a complex landscape of opportunities and ...
The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...