FDA News

The approval allows patients to begin lecanemab treatment at home via weekly subcutaneous injection, eliminating the 18-month IV requirement that previously preceded any at-home dosing.

Catch up on any of the neurology headlines you may have missed in June 2026, compiled into 1 place by the NeurologyLive® team.

The 510(k) clearance was supported by a 3-study, 159-patient registrational program showing a 45.5% increase in response rate vs physical therapy alone, and includes Medicare coverage at launch.

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 Alzheimer's Association International Conference 2026 .

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.

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]

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.

Bevacizumab becomes approved in Japan for neurofibromatosis type 2 following phase 2 data that suggested potential effects on hearing preservation and tumor volume despite the study not meeting its primary efficacy end point.

The FDA has accepted Regeneron Pharmaceuticals’ new drug application of cemdisiran's for generalized myasthenia gravis under priority review, with a target action date of November 2026.

Phase 3 data showed a 53% reduction in relapse risk versus placebo, and ecopipam could become the first non-antipsychotic option ever approved for Tourette syndrome.

The FDA indicated that 3-year phase 1/2 data may support a BLA submission for AMT-130, an investigational gene therapy that previously demonstrated significant slowing of Huntington disease progression in treated patients.

Catch up on any of the neurology headlines you may have missed in May 2026, compiled into 1 place by the NeurologyLive® team.

New exon‑51 skipping therapy boosts dystrophin and patient strength, with upcoming trial readouts aiming to support accelerated FDA approval.

The FDA's acceptance and priority review of levacetylleucine for ataxia-telangiectasia positions the therapy to potentially become the first approved treatment for the rare neurodegenerative disorder.

FDA priority review of asundexian marks a key regulatory milestone for factor XIa inhibition in secondary stroke prevention following positive phase 3 OCEANIC-STROKE results.

Catch up on any of the neurology headlines you may have missed from last week, compiled into 1 place by the NeurologyLive® team.

The FDA has expanded the use of efgartigimod alfa-fcab and Hytrulo to include adults with AChR-Ab seronegative generalized myasthenia gravis, marking the first approved FcRn-targeted therapy for this patient population.

The FDA approval of ocrelizumab for pediatric RRMS expands access to a high-efficacy anti-CD20 therapy for children and adolescents with historically limited treatment options.

Clene plans to pursue accelerated FDA approval for CNM-Au8 in ALS based primarily on neurofilament light biomarker data and phase 2 studies, with a confirmatory phase 3 trial expected to follow.

Catch up on any of the neurology headlines you may have missed in April 2026, compiled into 1 place by the NeurologyLive® team.

FDA clears AXS-05 to ease Alzheimer dementia agitation, offering an oral option that significantly delays symptom relapse in long-term data.

FDA issues complete response letter for GTx-104 in aneurysmal subarachnoid hemorrhage, citing manufacturing and nonclinical concerns despite positive phase 3 efficacy and safety data.

The FDA has cleared an updated Cala kIQ Plus wearable system, adding adaptive features to support personalized management of hand tremor in essential tremor and Parkinson disease.

Neurology News Network for the week ending April 11, 2026. [WATCH TIME: 4 minutes]

FDA accepts Ultragenyx’s UX111 gene therapy BLA for Sanfilippo A, setting a September 2026 decision date.

Stay informed on the latest therapeutic advancements with this clinical recap from the NeurologyLive® team, featuring a centralized look at 7 FDA-approved treatments from the first quarter of 2026.