Europe to review safety data for Eisai-Biogen Alzheimer's drug
The European Commission has requested its medicines regulator to consider safety information on Eisai and Biogen's ...
GlobalData on MSN8d
Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing
The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...
EU to Weigh New Safety Data on Biogen, Eisai Alzheimer’s Drug
European Union regulators will review new information relating to the safety of Eisai Co.’s and Biogen Inc.’s medicine for ...
US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's ...
Merck Q4 Earnings & Sales Beat Estimates, Stock Down on Weak '25 View
MRK posts encouraging Q4 results. However, the decision to temporarily halt shipments of Gardasil vaccines to China has ...
Healio2h
FDA accepts BLA for Leqembi subcutaneous autoinjector maintenance dosing
The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...
Hosted on MSN1d
Biogen Stock Down on Regulatory Update in the EU for Alzheimer's Drug
Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...
GlobalData on MSN11d
MSD and Eisai’s LEAP gastroesophageal cancer trial sees mixed success
MSD and Eisai’s trial saw mixed success with its two primary endpoints, seeing success in progression-free survival, but ...
Biogen, Eisai: EC Asks CHMP to Take Another Look at Leqembi
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 ...
Seeking Alpha on MSN4d
Biogen, Eisai Alzheimer’s drug review delayed in EU
Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab.
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Eisai and Biogen Provide Update on Lecanemab Regulatory Review for Alzheimer’s Disease in the European Union
Eisai and Biogen update on lecanemab's EU regulatory review for early Alzheimer’s disease treatment following positive CHMP opinion. Eisai Co., Ltd. and Biogen Inc. have provided an update on ...