A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...

Zunveyl, an oral medication, is a better-tolerated version of galantamine for managing mild to moderate Alzheimer's symptoms.

The Office of the Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues ...

On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) ...

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report.

The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners ...

Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has accepted Eisai's Biologics ...

To date, Leqembi has been approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, GB, Mexico, and Macau, and ...

Recent studies implicate the immune system and a herpes virus as potential contributors to development of disease ...

Eisai is busy diversifying dosing administrations of its drug after Eli Lilly joined the Alzheimer’s treatment space with ...

Investors seeking the next obesity-like market opportunity will be closely watching developments related to treatments for ...