European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer's treatment lecanemab a few months after rejecting ...
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
BioPharma Dive1h
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing ...
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
ENDPOINTS NEWS2h
Eu­ro­pean drug reg­u­la­tor re­vers­es opin­ion on Ei­sai and Bio­gen's Alzheimer's drug
The European Medicines Agency has flipped its stance on Eisai and Biogen’s Alzheimer’s treatment Leqembi, recommending ...
Eisai receives positive CHMP opinion for Lecanemab in early Alzheimer’s disease
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
Biogen’s stock rises after E.U. regulator reverses negative view of Alzheimer’s drug
Biogen’s stock rose 1% Thursday, after Europe’s pharmaceutical regulator issued a positive opinion on the Alzheimer’s disease ...
AFP on MSN5h
European watchdog partially approves new Alzheimer's drug
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...
STAT5h
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be ...
Sanofi's Sarclisa Recommended for EU Approval
Sanofi said that Sarclisa, its treatment for plasma cell cancer, was recommended for EU approval by the European Medicines Agency. The agency's Committee for Medicinal Products for Human Use ...
Biogen, Eisai Win CHMP Backing of Leqembi Alzheimer's Drug
A key European regulatory panel has reversed course and is now recommending approval of Leqembi, the Alzheimer's drug from Biogen and Eisai. The companies on Thursday said the European Medicines ...