Neurocritical Care News

The FDA has approved breakthrough device designation for a novel neuroimmune modulation platform for those with relapsing-remitting multiple sclerosis, according to the manufacturer.

The FDA has granted breakthrough therapy designation to Cybin’s CYB003, a proprietary deuterated psilocybin analog in development for treatment of major depressive disorder, according to a company press release.

The FDA has approved Lenmeldy as the first gene therapy to treat children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy.

Agamree oral suspension 40 mg/mL is now commercially available in the United States for the treatment of Duchenne muscular dystrophy in patients aged 2 years and older, according to a press release.

The FDA has granted breakthrough designation to MM-120 for the treatment of generalized anxiety disorder, according to a press release from MindMed.

Long-term treatment with IV administration of a novel therapeutic for those with myotonic dystrophy type 1 led to significant improvement in muscle strength and control and improved quality of life, data show.

Treatment with viltolarsen at 48 weeks improved pulmonary function in a cohort of pediatric patients with Duchenne muscular dystrophy amenable to exon 53 skipping compared with those receiving standard care.

Treatment with givinostat for ambulatory boys with Duchenne muscular dystrophy led to improved motion and reduced decline of muscle function and strength at 18 months, according to a poster at the 2024 MDA Clinical & Scientific Conference.

For young ambulatory boys with Duchenne muscular dystrophy, treatment with pamrevlumab was nonsuperior to placebo after 52 weeks, according to a poster presentation at the 2024 MDA Clinical & Scientific Conference.

WEST PALM BEACH, Fla. — Oral administration of vidofludimus calcium reduced fatigue over 14 days compared with placebo and may have a long-term positive effect in multiple sclerosis, according to a poster presented at ACTRIMS 2024.