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

Denali Therapeutics' DNL343 fails to slow ALS progression in phase 2/3 trial but shows safety and offers insights for future ...

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...

A clinical trial evaluating the drug fosigotifator in patients with amyotrophic lateral sclerosis has failed to meet its primary endpoint, according to topline results from the Healey ALS platform ...

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.

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 ...

Like many brain diseases, ALS has been exceptionally difficult to crack for even the world’s most powerful drug developers. Only a few medicines have received approval from the Food and Drug ...

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 ...