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.
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
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).
Eisai and Biogen’s subcutaneous Leqembi set for FDA review
Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration (FDA) accepted a biologics licence application (BLA) for a subcutaneous version of the drug.
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
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 ...
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 ...
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 ...
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 ...
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.
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 ...