NKGen Biotech said it’s been cleared to launch an expanded access program (EAP) that will allow patients in the U.S. with neurodegenerative conditions, including amyotrophic lateral sclerosis (ALS), to access its experimental therapy troculeucel outside clinical trials. EAPs, or compassionate use programs, allow people with serious or life-threatening conditions…

A new treatment approach that noninvasively delivers gentle electrical stimulation to the spinal cord and peripheral nerves — the nerves that connect the brain and spinal cord to the rest of the body — was found to slow disease progression and extend survival in a mouse model of amyotrophic…

A coalition of amyotrophic lateral sclerosis (ALS) patients and their family members has filed a petition to the U.S. Food and Drug Administration (FDA) asking the agency to review again available data for the stem cell therapy NurOwn (debamestrocel). The petitioners include ALS patients who received NurOwn in…

Clene has incorporated suggestions from the U.S. Food and Drug Administration (FDA) on its analysis plans for certain biomarker data that’s expected to support an accelerated approval application for CNM-Au8 to treat amyotrophic lateral sclerosis (ALS), the company has announced. Specifically, the FDA had suggested revisions to…

Clinicians view early access to palliative care as beneficial for people with amyotrophic lateral sclerosis (ALS), yet its integration into routine care remains inconsistent, a U.S. study found. About two-thirds of ALS clinicians said they had a palliative care specialist on their team, and just over half of ALS…

Brainstorm Cell Therapeutics is partnering with Minaris Advanced Therapies to manufacture NurOwn (debamestrocel), its investigational cell therapy for amyotrophic lateral sclerosis (ALS), for an upcoming Phase 3b clinical trial. The companies signed a letter of intent outlining the collaboration, under which Minaris, a contract development and manufacturing…

ATH-1105, an experimental oral therapy for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, was found to be safe and well tolerated in healthy volunteers, according to the treatment’s developer, Athira Pharma. The data comes from a first-in-human Phase 1 trial (NCT06432647) that tested the safety and pharmacological…

I remember the emptiness I felt the first September after graduating from college. I’d been a student for 16 of my 21 years at that time, and the void of not going back to school at the end of summer was disconcerting. For some years after that, I quietly regarded…

Neurosense Therapeutics said it’s scaled production of PrimeC, its oral therapy for amyotrophic lateral sclerosis (ALS), to commercial levels as it awaits regulatory approval to launch the medication in Canada. “This manufacturing milestone represents a critical leap forward in our commercialization roadmap,” Alon Ben-Noon, CEO of Neurosense, said in…

The other day when I sat down at my computer, I discovered a small, beige envelope that had been left near my workspace. To my surprise, inside was a letter addressed to me from the rollator that helps me live with ALS. After a quick read of the note,…