Health Canada has authorized a new drug submission for masitinib — AB Science’s add-on therapy for amyotrophic lateral sclerosis (ALS) — under the notice of compliance with conditions policy (NOC/c), designed to get new medications to patients more quickly. If granted, this would allow conditional marketing of…
A U.S. Food and Drug Administration (FDA) advisory committee has scheduled a virtual meeting with Amylyx Pharmaceuticals to review its application for the approval of AMX0035 to treat amyotrophic lateral sclerosis (ALS), the company announced. The online meeting to discuss data supporting the approval request is set for March 30.
NP001 slowed functional and lung declines in a subset of middle-aged patients with amyotrophic lateral sclerosis (ALS) who had high levels of inflammation, according to an analysis of previous data from Phase 2a and 2b clinical trials. While earlier results failed to show overall…
Urine levels of neopterin, a marker of inflammation, are linked to disease progression in people with amyotrophic lateral sclerosis (ALS), a study revealed. That means, according to researchers, that neopterin could be used as a biomarker to monitor disease status and determine whether certain treatments will be effective. The…
The U.S. Food and Drug Administration (FDA) has approved a Phase 2 clinical trial of the psychedelic ketamine, PharmaTher’s experimental treatment for amyotrophic lateral sclerosis (ALS). FDA approval was requested through an investigational new drug application (IND) submitted by the study’s principal investigator, Richard Barohn, MD, a neurologist…
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