The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease agitation.
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.
The FDA has granted Orphan Drug designation to NT-I7 (efineptakin alfa; NeoImmuneTech) for the treatment of progressive multifocal leukoencephalopathy.
Acadia Pharmaceuticals has submitted a supplemental New Drug Application to the FDA for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis.
The FDA has cleared EndeavorRxTM for use as a prescription-only video game-based digital therapeutic to improve attention function in pediatric patients aged 8-12 years with primarily inattentive or combined-type ADHD.
The two, 6-week, multicenter, double-blind, placebo-controlled trials (Study 1 and Study 2) evaluated the efficacy and safety of centanafadine sustained-release tablets in approximately 900 adult patients with ADHD.
New data from the phase 2 NURTURE trial evaluating nusinersen demonstrate that presymptomatic patients with spinal muscular atrophy continue to benefit from treatment for up to 4.8 years.
The FDA has approved inebilizumab for the treatment of neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive.
Findings from the study showed 44% of patients treated with berubicin experienced a statistically significant improvement in progression free survival.