The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with ...
The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with ...
The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
EU drugs regulator recommends approval of Leqembi for early Alzheimer's, pending European Commission acceptance, for specific ...
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...
The firm said Biogen partner Eisai’s request for the EMA’s CHMP to reexamine the MAA for lecanemab in amyloid-positive early Alzheimer’s disease has paid off with a positive recommendation that ...
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
Biogen’s stock rose 1% Thursday, after Europe’s pharmaceutical regulator issued a positive opinion on the Alzheimer’s disease ...
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...