Denali Therapeutics Inc.'s stock remains stable despite trial setback in ALS. BLA filing for MPS II treatment on track. Click ...

and is willing to consider how EAP data can help ALS drugs advance on regulatory pathways.” Merit Cudkowicz, MD, Chair, Neurology Department, Massachusetts General Hospital, Director ...

and is willing to consider how EAP data can help ALS drugs advance on regulatory pathways.” Merit Cudkowicz, MD, Chair, Neurology Department, Massachusetts General Hospital, Director, Sean M Healey & ...

and is willing to consider how EAP data can help ALS drugs advance on regulatory pathways.” Merit Cudkowicz, MD, Chair, Neurology Department, Massachusetts General Hospital, ...

It's a vote of confidence in the drug after an FDA ... as quickly as possible following regulatory approval. There is simply no time to wait with this disease." In ALS, which is also known as ...

Kinsey is an advocate who was diagnosed with ALS in 2024 ... through the FDA’s accelerated pathway — a program designed to expedite the approval of drugs for life-threatening conditions.

FDA's accelerated approval pathway ... drug. The agency said it expects insurers to contact patients who were inappropriately denied coverage of the drug to inform that policies have changed. The ...