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

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.

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

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

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 ...

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

The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for subcutaneous (SC) maintenance dosing of lecanemab-irmb for the treatment of Alzheimer disease (AD) in ...

The agency expects to issue a decision by Aug. 31, and it is slated to decide on maintenance dosing for an intravenous form of the drug later this month.

or mild dementia stage of disease (collectively referred to as early AD). Leqembi is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection ...

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

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