A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.

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

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.

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

If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The ...

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

LEQEMBI® [ (lecanemab-irmb) 100 mg/mL injection for intravenous use] is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild ...

Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment ...

Alzheimer's disease is the most common type of dementia. Here, we break down what to know about this disease, including: What ...

As the J.P. Morgan Healthcare Conference enters its second day, we're tracking presentations from GSK, Novartis, Sanofi, Eli ...

Anavex's financial health is stable with cash runway into 2028, but rising expenses are expected. Click here to find out why ...