A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer's medicine available in the ...
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be ...
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...
MEDIA RELEASEAfqlir® (aflibercept) approved to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD)One ...
Bristol Myers Squibb (NYSE:BMY) has received a recommendation for approval from the Committee for Medicinal Products for ...
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three ...
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.
Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...