FDA Action Update, September 2026: Approvals, Clearances, and Priority Review

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending October 16, 2026.

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

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

The designation follows phase 2 ClearMEMory data in which the oral NMDA receptor antagonist improved objective cognitive performance over placebo at 12 weeks.

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending October 9, 2026.

The phase 2 FENerations1 study is an open-label, single-arm, small-scale study evaluating fenebrutinib dosing in 8 to 12 children and adolescents with relapsing MS.

Updated data from Breakfree-2 study showed that treatment with a single zola-cel infusion achieved NEDA-3 in highly active relapsing multiple sclerosis and led to mostly stable disability in progressive multiple sclerosis.

Data from the real-world, CONFIDENCE study found switching from intravenous to subcutaneous ocrelizumab was well tolerated in patients with relapsing and primary progressive MS.