The FDA has set a Prescription Drug User Fee Act action date for 24 May 2026.

Eisai and Biogen recently announced that the U.S. FDA has accepted for Priority Review a supplemental Biologics License Application for LEQEMBI IQLIK, a subcutaneous weekly autoinjector starting dose ...

Biogen Inc.’s new at-home Alzheimer’s drug will give the company an edge over rival Eli Lilly Co.’s competing therapy, its ...

Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with ...

Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting ...

LEQEMBI is currently approved in 53 countries and regions and is under regulatory review in 7 countries. In August 2025, the US FDA approved LEQEMBI IQLIK 360 mg for weekly subcutaneous maintenance ...

During the first day of the 44 th Annual JP Morgan Healthcare Conference in San Francisco, a clear narrative emerged. With the looming patent cliff, companies are focused on their pipelines and making ...

Eisai and Biogen’s Supplemental Biologics License Application (sBLA) for Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) has been accepted by the US FDA under Priority Review to treat early ...

The U.S. Food and Drug Administration (FDA) stated on Thursday that it is requiring an additional MRI scan for Alzheimer's patients receiving Leqembi (lecanemab), citing safety concerns over a rare ...

Biogen (NASDAQ:BIIB) traded ~8% higher in the premarket on Thursday after the company posted better-than-expected financials for Q2 2025, thanks mainly to a strong uptake for its Alzheimer’s therapy ...

With Biogen gaining FDA approval for its Alzheimer’s drug, aducanumab, questions have started to swirl around how health insurers will cover the $56,000-a-year treatment. 1. The FDA approved Biogen’s ...