Merck MRK reported fourth-quarter 2024 adjusted earnings per share (EPS) of $1.72, which beat the Zacks Consensus Estimate of $1.69. In the year-ago period, management reported adjusted EPS of 3 cents ...

The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...

Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...

Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab.

The U.S. Food and Drug Administration approved Eisai and Biogen’s application for IV maintenance dosing of lecanemab on January 27. Previously, the label called for biweekly IV dosing. The new ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two ...

In recent health developments, Akero Therapeutics' drug shows promise for liver disease, Eisai/Biogen's Alzheimer's drug ...

The Japanese and American based pharma companies announced a win for their Alzheimer’s treatment, which has faced some negative backlash over the last year.

The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...