The European Commission had requested the committee consider new data on the drug that became available after it had adopted its positive opinion.

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has ...

Eisai announces Leqembi sales reaches €200 million; BioArctic to receive €10 million payment: Stockholm, Sweden Wednesday, February 19, 2025, 14:00 Hrs [IST] BioArctic AB’s ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has notified BioArctic that the first sales milestone according to the licensing agreement ...

"We still wait on updates around European Leqembi approval, after the European Commission asked the CHMP to consider two additional questions (to be discussed in February) after the CHMP adopted a ...

Biogen BIIB reported fourth-quarter 2024 adjusted earnings per share (EPS) of $3.44, which beat the Zacks Consensus Estimate of $3.42. Earnings rose 17% year over year on a reported basis, boosted by ...

Biogen posted fourth-quarter revenue and profit that topped expectations as its cost cuts showed progress and new products, including its breakthrough Alzheimer's treatment Leqembi, saw growth.