Oral Suspension Formulation of Edaravone Approved for ALS
The approval of Radicava ORS was based on a bioavailability study and a safety study.
Amyotrophic Lateral Sclerosis
FDA Panel Votes on Fixed-Dose Combination Therapy for ALS
AMX0035 is an oral, fixed-dose coformulation of sodium phenylbutyrate and taurursodiol, also known as ursodoxicoltaurine.
Oral Formulation of Edaravone Gets Priority Review for ALS
Oral edaravone was developed to have a similar clinical profile as the intravenous formulation Radicava.
Fixed-Dose Combo Therapy for ALS Gets Priority Review
AMX0035 is an oral, fixed-dose coformulation of sodium phenylbutyrate and taurursodiol, also known as ursodoxicoltaurine.
Sodium Phenylbutyrate-Taurursodiol Coformulation for ALS Submitted for Review
The application is supported by data from the phase 2 CENTAUR trial, along with the open-label extension study.
Trial Evaluating Ravulizumab for Amyotrophic Lateral Sclerosis Discontinued
Following a prespecified interim analysis, the decision to halt the study was made based on the recommendation from the Independent Data Monitoring Committee.
Pridopidine Granted Orphan Drug Status for Amyotrophic Lateral Sclerosis
Pridopidine is an investigational oral drug that binds and activates the sigma-1 receptor, a protein that is highly expressed in the brain.
Exservan Now Available for Amyotrophic Lateral Sclerosis
According to the CDC, more than a thousand cases of myocarditis and pericarditis following mRNA COVID-19 vaccination have been reported to the Vaccine Adverse Event Reporting System since April 2021.
Trehalose Designated Orphan Drug for ALS
SLS-005 contains the active ingredient trehalose, a low molecular weight disaccharide that crosses the blood brain barrier, stabilizes proteins and activates autophagy.
Investigational Drug May Prolong Survival in Patients With ALS
Median survival 6.5 months longer with initiation of PB-TURSO treatment compared with placebo.
