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FDA Action Update, January 2026: Approvals, Acceptance, and Clearance

BTK Inhibitor Fenebrutinib Shows Noninferiority to Ocrelizumab in Phase 3 Study of Primary Progressive MS

Published SPACE Study Reinforces Efficacy of Fremanezumab for Pediatric Episodic Migraine

FDA Accepts New Drug Application for Orexin Agonist Oveporexton in Narcolepsy Type 1, Grants Priority Review

NeuroVoices: Katrina Bawden, MSN, MSCN, FNP-C, on Emerging Therapies and Women’s Health Priorities in Multiple Sclerosis

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Late-breaking data from the 2026 ACTRIMS Forum showed that bazedoxifene acetate failed to improve remyelination outcomes in midlife women with relapsing MS, despite a favorable safety profile.

Phase 3 DAWN data show daratumumab cuts NMOSD relapse risk 76%, stays well tolerated, and may improve disability, signaling a new targeted option.

ACP urged to drop “provider” for physicians, warning it blurs expertise, commodifies care, and erodes professional identity, trust, and the patient relationship.

Ava L. Liberman, MD, assistant professor of clinical neurology at Weill Cornell Medicine, shared key takeaways from stroke data presented at the 2026 International Stroke Conference.

Neurologists Michael Levy, MD, PhD, and Fu-Dong Shi, MD, PhD, discuss the rationale, design, and clinical implications of the phase 3 DAWN trial evaluating daratumumab in aquaporin-4–positive NMOSD.

The FDA issued a CRL for gene therapy RGX-121 in Hunter syndrome, citing trial design and biomarker doubts; Regenxbio seeks a meeting with the agency and resubmission.

Pediatric neurologist Charuta Joshi, MD, discussed global disparities in epilepsy for children and adolescents amid International Epilepsy Day, highlighting opportunities for education, stigma reduction, and improved care access.

AGNOS trial showed that monthly treatment with ofatumumab lowered NfL and GFAP in patients with early RRMS, signaling reduced nerve damage and bolstering first-line treatment potential.

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

Ultragenyx seeks FDA accelerated approval for UX111 gene therapy in Sanfilippo syndrome, citing neurologic benefit and the use of cerebral spinal fluid heparan sulfate data.

The single-arm CLAD-MAPET study is evaluating whether cladribine tablets reduce microglial activation, captured by [F-18]PBR06-PET, in patients with MS experiencing progression without relapse or MRI activity on anti-CD20 therapy.

A real-world study showed that cladribine tablets were associated with greater treatment persistence and lower health care costs in patients with multiple sclerosis compared with other common therapies.

A new comparison study of patients with autoimmune diseases reported high rates of anxiety and depression, with notable differences in when psychiatric symptoms emerged relative to disease onset.

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending February 6, 2026.

A phase 3b study presented at ACTRIMS 2026 is evaluating whether switching to remibrutinib offers efficacy and safety comparable to continued ocrelizumab treatment in relapsing multiple sclerosis.
































