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FDA, Eisai and Biogen

US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug

The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday. The drug received standard U.

Business Insider · 4h

FDA approves Eisai, Biogen’s sBLA for lecanemab-irmb IV dosing

Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License

Mena FN · 6m

FDA Approves IV Maintenance Dosing Of Leqembi® (Lecanemab-Irmb) For The Treatment Of Early Alzheimer's Disease In The US

Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

2don MSN

Merck, Eisai's combination drug fails in late-stage trial for esophageal cancer

Merck and Japan-based Eisai said on Friday a combination of their therapies failed to extend the lives of patients with a ...

FDA Approves Once-Every-Four-Weeks Maintenance Dosing Of LEQEMBI For Early Alzheimer's Disease

Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the ...

GlobalData on MSN2d

MSD and Eisai’s LEAP gastroesophageal cancer trial sees mixed success

MSD and Eisai’s trial saw mixed success with its two primary endpoints, seeing success in progression-free survival, but ...

Merck and Eisai's cancer drugs fail to improve overall survival in late-stage trial

Merck's blockbuster drug Keytruda and Eisai's cancer drug Lenvima, in combination with chemotherapy, failed to improve ...

FiercePharma2d

Merck, Eisai's star-crossed Keytruda-Lenvima combo misses survival goal in GI cancer trial

Merck & Co. and Eisai have to deal with the reality that yet another phase 3 trial of their combination of Keytruda and ...

Nikkei Asia4d

Eisai eyes fiscal 2025 U.S. approval for home version of Alzheimer's drug

TOKYO -- Japanese drugmaker Eisai will make its Alzheimer's disease treatment Leqembi available for at-home administration by ...

Merck, Eisai See Mixed Keytruda/Lenvima Results in Phase 3 Gastroesophageal Cancer Study

Merck & Co. and Eisai reported mixed results from a late-stage study of the cancer drugs Keytruda and Lenvima in patients with certain types of gastroesophageal cancer.

Merck/Eisai's Keytruda Plus Lenvima Regime Shows Mixed Data In Esophagus Cancer Study

Merck and Eisai report mixed results from LEAP-015 trial of Keytruda and Lenvima in HER2-negative gastroesophageal cancer treatment.

Medindia2m

FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment TOKYO and CAMBRIDGE, Mass., Jan. 26, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: ...

BioPharma Dive2d

Mixed results for Keytruda; AbbVie to work with Neomorph

Merck and Eisai reported new data for a drug regimen of Keytruda and Lenvima. Elsewhere, AstraZeneca expanded in Canada and ...

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