In a landmark decision, the European Commission (EC) has authorized Biogen Inc.’s SKYCLARYS (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. This approval heralds SKYCLARYS as the first medication sanctioned within the European Union for this rare, genetic, and progressively debilitating neurodegenerative disease, promising a new […]
Connecticut-based Biohaven Pharmaceutical has received a significant regulatory boost, with the US FDA granting orphan drug designation for its investigational drug verdiperstat for treating multiple system atrophy (MSA). This rare and debilitating neurodegenerative disease has long been a target for pharmaceutical companies seeking breakthroughs in treatment, and verdiperstat’s designation underscores its potential as a game-changer […]