Neurocritical Care News

The European Commission has authorized a subcutaneous injection of Ocrevus to treat relapsing multiple sclerosis as well as primary progressive MS, according to the manufacturer.

The FDA has announced approval of a label expansion for Elevidys to include patients with Duchenne muscular dystrophy aged 4 years and older with a confirmed mutation in the DMD gene.

The FDA has approved Vyvgart Hytrulo in a once-weekly, 30- to 90-second subcutaneous injection to treat adults with chronic inflammatory demyelinating polyneuropathy, according to the manufacturer.

The FDA has granted Regenerative Medicine Advanced Therapy designation to a novel regenerative cell therapy to treat drug-resistant mesial temporal lobe epilepsy, according to the manufacturer.

The FDA has approved an abbreviated new drug application for a generic version of Emflaza to treat Duchenne muscular dystrophy, according to the manufacturer.

Newly released data from the open-label extension of the FIREFISH study confirmed sustained safety and efficacy of Evrysdi in children with type 1 spinal muscular atrophy over 5 years.

Prothena Corp. recently announced it would receive $80 million from Bristol Myers Squibb for an exclusive global license to an investigational therapeutic developed to address protein dysregulation.

The FDA has granted an expanded indication for BrainsWay’s Deep Transcranial Magnetic Stimulation system for depression treatment in patients aged 22 to 86 years, according to a company press release.

The FDA has selected an investigational AAV9 gene therapy for Rett syndrome to participate in a pilot program created to provide a boost to novel drug development for rare diseases, according to a release from the manufacturer.

DENVER — Subcutaneous administration of ocrelizumab showed similar safety and efficacy profiles to IV administration in multiple sclerosis at 24 weeks, according to David Jones, senior medical director at Genentech.