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The 510(k) clearance was supported by a three-study, 159-patient registrational program showing a 45.5% increased response rate versus physical therapy alone, and includes Medicare coverage at launch.

New phase 2b PARADIGM data showed PrimeC significantly reduced neuron-derived TDP-43 levels in patients with ALS while reinforcing previously reported improvements in disease progression and survival.

Tom Fuchs, MD, PhD, postdoctoral researcher at the MS Center at Amsterdam University Medical Center, shared his reaction to the European Commission's approval of tolebrutinib for nonrelapsing secondary progressive MS.

Results from the Baby-COMET study of avalglucosidase alfa in infantile-onset Pompe disease will support a planned US regulatory submission for a label extension, anticipated in the second half of 2026.

Twelve-month phase 1/2 data show SKY-0515-treated patients trending favorably versus natural history expectations across motor, functional, and cognitive endpoints, while 65% of patients and 50% of clinicians reported disease improvement.

New findings suggest that monoclonal antibody therapy was associated with a 34% lower risk of relapse in patients with AQP4-IgG seropositive NMOSD compared with those who were seronegative.

The professor of neurology at Wake Forest School of Medicine discussed the evolution of sleep medicine education, its relevance across neurologic specialties, and advice for early-career clinicians.

The FDA accepted supplemental applications seek to convert the accelerated approvals of casimersen and golodirsen to traditional approvals in patients with Duchenne muscular dystrophy.

Additional analyses from a phase 2 study evaluating the effects of zervimesine on hallucination in DLB will be presented at the upcoming 2026 Alzheimer's Association International Conference.

The FDA will review Capricor Therapeutics' deramiocel for the treatment of Duchenne muscular dystrophy on July 29, 2026, ahead of the therapy's PDUFA target action date of August 22, 2026.

Jens Kuhle, MD, PhD, head of the Multiple Sclerosis Centre at University Hospital Basel, discusses the EU approval of tolebrutinib for nonrelapsing SPMS and its implications for treating disability progression.

The ongoing phase 3 RELIEVE trial investigates the efficacy and safety of remibrutinib in patients with generalized myasthenia gravis who are on stable standard-of-care treatment.

A non-randomized controlled trial found that an MCT program added to standard rehabilitation significantly improved MoCA scores and reduced anxiety and depression at 4 and 12 weeks compared with standard care alone.

Johnson, who set the single-season NFL rushing record in 2009, went public with his diagnosis on Good Morning America, saying he hopes his story accelerates research and awareness of the disease.

A $2.5 million Michael J. Fox Foundation grant is funding 4 new sites for the NEULARK trial assessing NEU-411 as a potential disease-modifying therapy in genetically selected patients with early Parkinson disease.

Here's some of what is coming soon to NeurologyLive® this week.

Test your neurology knowledge with NeurologyLive®'s weekly quiz series, featuring questions on a variety of clinical and historical neurology topics. This week's topic is sex-based differences in neurology!

Movement disorder experts Jonathan Isaacson, MD, and Abhishek Lenka, MD, PhD, discuss early identification and accurate diagnosis of autonomic dysfunction in Parkinson disease, highlighting emerging biomarkers and monitoring tools that may enable more personalized care.

A recently published 20-year study suggests that preoperative putamen volume on MRI independently can predict motor response to GPi-DBS in patients with dystonia-dyskinesia syndrome secondary to perinatal hypoxic-ischemic encephalopathy.

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending June 26, 2026.

Following the FDA's expanded approval of efgartigimod, the neuromuscular physician at Erlanger Health Systems discusses the implications for seronegative disease, treatment sequencing, and the evolving definition of antibody-negative MG. [WATCH TIME: 5 minutes]

Doris D. Wang, MD, PhD, Associate Professor of Neurological Surgery at UCSF, discusses a newly published adaptive deep brain stimulation system that adjusts in real time during walking and what it means for the future of Parkinson disease care.

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Grace Gombolay, MD; and Varun Kannan, MD. [LISTEN TIME: 25 minutes]

At ATMRD 2026, a neurologist at UCLA discussed the growing recognition of demoralization in Parkinson disease, highlighting how it differs from depression and apathy and outlining strategies to help patients maintain resilience, purpose, and quality of life. [Watch time: 5 minutes]

REGENXBIO expects to resubmit the BLA for clemidsogene lanparvovec in Q3 2026 after the FDA confirmed existing CAMPSIITE data are sufficient for accelerated approval consideration.

The European Commission has approved Cenrifki (tolebrutinib) for nrSPMS without relapses in the last two years, a milestone that arrives despite the drug's failed US submission and a regulatory pathway that has been anything but linear.

The chief scientific officer of the Parkinson’s Foundation discussed how the PD Trial Navigator program helps to identify individuals with Parkinson Disease who may be eligible for the phase 2 NEULARK study. [WATCH TIME: 4 minutes]

Ashish Raj, PhD, professor of radiology and biomedical imaging at UCSF, discusses a newly developed AI model that predicts current and future cognitive impairment from a single baseline MRI scan in patients across the Alzheimer disease spectrum.