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…
FDA Grants Priority Review to ALS Therapy AMX0035
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…
Columns
Making Game Nights Work
It feels like a win when we can figure out how to include my husband, Todd, in game nights. He is paralyzed because of amyotrophic lateral sclerosis (ALS), so any game that requires writing or moving is a challenge. That would include most games, but we can make some…
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…
Columns
We Must Rely on Our Resilience
Lately, living with ALS amid the continuing world health crisis has me dialing my resilience-meter up to “high.” Why? Both have limited treatments and no cure in sight, and convert our old “normal” lives into an ever-changing world of new normal. And both require resilience. Resilience is our ability to…
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)…
“How am I supposed to drive when I can’t see anything?” my nearly 16-year-old daughter asked. Sara and I were logging night-driving hours, which are required before she can take the second segment of driver’s education in January. She already has 12 hours behind the wheel, mostly during the day,…
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…
“Catch a Cannonball, now, to take me down the line My bag is sinkin’ low and I do believe it’s time To get back to Miss Fanny, you know she’s the only one Who sent me here with her regards for everyone Take a load off Fanny Take a load…
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