Showing 2679 results for "amyotrophic lateral sclerosis (ALS)"

Seelos’ SLS-005 Cleared as 5th Arm of HEALEY ALS Trial

Seelos Therapeutics’ experimental therapy SLS-005 (trehalose) will serve as the fifth arm of the multi-regimen HEALEY trial for amyotrophic lateral sclerosis (ALS), after being cleared by the U.S. Food and Drug Administration and the Mass General Brigham Institutional Review Board. With this final regulatory authorization, Seelos may still…

Amylyx Plans to File for Approval of AMX0035 in US

Amylyx Pharmaceuticals plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the coming months for approval of its investigational oral therapy AMX0035 for amyotrophic lateral sclerosis (ALS). The decision follows recent discussions with the FDA, including a pre-NDA meeting held…

Alector, GSK Team Up to Develop 2 Antibody Treatments for ALS

Alector and GlaxoSmithKline (GSK) have established a partnership to develop two investigational antibodies — called AL001 and AL101 — to boost the production of the progranulin protein as a potential treatment for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS). Low levels of progranulin, known as PGRN, which is a…

Exservan, Riluzole Oral Film for ALS, Now Available in US

Exservan, the first oral film formulation of riluzole for treating amyotrophic lateral sclerosis (ALS), has been launched in the United States, its developer, Mitsubishi Tanabe Pharma America (MTPA), has announced. Rapidly dissolved when placed on top of the tongue, Exservan — specifically developed to help meet the needs…

Amylyx Seeks Approval in Canada of Lead Candidate AMX0035

Amylyx Pharmaceuticals is seeking approval, in Canada, of its lead candidate AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). This regulatory submission “represents a significant milestone in our efforts to develop a new treatment option for people living with ALS who have no time to wait,” Joshua Cohen, co-founder, co-CEO,…