The U.S. Food and Drug Administration (FDA) has accepted for review Amylyx Pharmaceuticals‘ application seeking approval of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The new drug application (NDA) also was granted priority review by the regulatory agency, which reduces review time from the standard…
ALS News Today brought you daily coverage of the latest scientific breakthroughs and clinical research related to amyotrophic lateral sclerosis (ALS) throughout 2021. We look forward to continuing to report for the ALS community in 2022. Here are the 10 most-read ALS news articles of the last year, with…
Amyotrophic lateral sclerosis (ALS) patients who completed the expanded access protocol (EAP) for NurOwn may soon be eligible for three additional doses of the cell-based therapy, BrainStorm Cell Therapeutics reported. EAPs, also known as compassionate use programs, are intended to make investigational therapies available outside of a clinical trial…
A new partnership between Target ALS and the Alzheimer’s Drug Discovery Foundation (ADDF) will help facilitate biomarker research in neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and frontotemporal dementia (FTD). Identifying and validating appropriate biomarkers can help clinicians diagnose these diseases earlier, reliably track…
The largest collection of amyotrophic lateral sclerosis (ALS) clinical trial data, amassed to help researchers globally find better treatments and potentially a cure for the progressive neurological disorder, was awarded the $50,000 Healey Center International Prize for Innovation in ALS. The Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT)…
Amydis announced plans to launch a first clinical trial next year into the ability of its small molecule tracer to detect toxic TDP-43 clumps — a hallmark of amyotrophic lateral sclerosis (ALS) — in the eye’s retina. Its announcement follows a preliminary meeting with U.S. Food and Drug Administration…
If signed by President Joe Biden, the bipartisan Accelerating Access to Critical Therapies (ACT) for ALS Act will fund crucial research into fast-progressing neurodegenerative disorders such as amyotrophic lateral sclerosis (ALS) and provide patients with early access to promising treatment candidates. The legislation (HR 3537), which has passed the…
Athletes who have played in the National Football League (NFL) are significantly more likely than the general population to develop amyotrophic lateral sclerosis (ALS), according to a new study. “These findings indicate that athletes who played in the NFL have a nearly 4 times greater rate of developing, and…
Amyotrophic lateral sclerosis (ALS) leads to neuron damage in an eye layer called the retina through the activation of pro-inflammatory microglia, or immune cells of the brain and spinal cord, a study in a mouse model of the disease suggests. Consistent with previous evidence of retinal damage in…
A significantly greater proportion of amyotrophic lateral sclerosis (ALS) patients with less severe disease showed slower ALS progression with the investigational cell-based therapy NurOwn relative to a placebo. These are the findings of another post-hoc analysis of data from NurOwn’s Phase 3 clinical trial (NCT03280056), further supporting the…
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