Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...
US regulators approved Leqembi in 2023 and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved the ...
If the European Commission decides to grant sales of the medicine, it will be the first Alzheimer's medicine available in the ...
EU drugs regulator recommends approval of Leqembi for early Alzheimer's, pending European Commission acceptance, for specific ...
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer's disease, reversing an earlier decision not to give it the green light.
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.
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
The European Medicines Agency has flipped its stance on Eisai and Biogen’s Alzheimer’s treatment Leqembi, recommending ...
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease, in adult patients who are heterozygotes (carry one copy) ...