FDA final approval decision on NurOwn for ALS due by year’s end

A final decision by the U.S. Food and Drug Administration (FDA) on whether or not to approve NurOwn for amyotrophic lateral sclerosis (ALS) is now expected no later than Dec. 8. But before that, on Sept. 27, an FDA advisory committee will meet to review the potential benefits…

Bill Nuti, the former CEO and chairman of NCR Corporation, is on a mission to eliminate amyotrophic lateral sclerosis (ALS). Nuti, who stepped away from NCR in 2018 after being diagnosed with ALS, has launched CureALS, a nonprofit that will draw on funding, partnerships, data sourcing, and artificial intelligence…

Every once in a while, I step onto my soapbox (mine has special safety rails) to voice my view about an important issue in the ALS community. This time, I’m here with praise for “ALS and Mental Health,” an article recently published in ALS News Today. In my…

A messenger RNA (mRNA) molecule that provides the instructions for a protein involved in glutamate signaling is not edited as efficiently in amyotrophic lateral sclerosis (ALS) patients as in people without the neurological disorder, according to a new study suggesting its potential use as an ALS biomarker. Glutamate is…

Apellis Pharmaceuticals’ investigational therapy pegcetacoplan (APL-2) has failed to improve a combined assessment of function and survival in people with amyotrophic lateral sclerosis (ALS), according to top-line data from the MERIDIAN Phase 2 clinical trial. While the treatment was well tolerated, consistent with its established safety profile,…

Today marks the third annual Major League Baseball (MLB) Lou Gehrig Day, set aside to honor the legacy of the famed New York Yankees first baseman whose career was shortened by amyotrophic lateral sclerosis (ALS). For the first time since the event began, all 30 MLB teams have…

I don’t like asking for help, but when it’s for my husband, I’ll do it. Last Friday, after getting my kids out the door for school, they quickly returned to the house. “The car has a flat tire,” my daughter announced. “I’ll drive you,” I responded.

A committee of the European Medicines Agency (EMA) is leaning toward not recommending a conditional approval of Amylyx Pharmaceuticals’ AMX0035 for treating amyotrophic lateral sclerosis (ALS) in the European Union. The drug is already marketed in the U.S. under the name Relyvrio (sodium phenylbutyrate and taurursodiol) and…

Every once in a while, I have to stop and declare, “I’m spinning way too many plates!” That happens whenever I begin to feel overwhelmed by the number of tasks I’ve set myself up to do while living with ALS. You’ve seen plate spinning, right? It was…