The U.S. Food and Drug Administration (FDA) has granted priority review to an application from Sanofi seeking the approval of its BTK inhibitor tolebrutinib to treat multiple sclerosis (MS). As its name suggests, priority review means that the FDA will speed its regulatory evaluation of the oral therapy,…

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Sanofi’s BTK inhibitor candidate tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (SPMS). According to Sanofi, tolebrutinib is the first investigational BTK inhibitor with the ability to reach the brain…

The U.S. Food and Drug Administration (FDA) has granted fast track status to KYV-101, Kyverna Therapeutics’ cell-based therapy candidate for people with progressive forms of multiple sclerosis (MS) that are treatment-resistant. The FDA designation is intended to accelerate the development of therapies that aim to address unmet medical…

The U.S. Food and Drug Administration (FDA) has placed a partial hold on Genentech’s ongoing Phase 3 clinical trials testing fenebrutinib for the treatment of relapsing and primary progressive forms of multiple sclerosis (MS). The decision was based on two cases of patients who experienced elevations in their…

A test called Elecsys NfL  — developed by Roche to measure blood levels of the nerve damage biomarker neurofilament light chain (NfL) in people with multiple sclerosis (MS) — has received breakthrough device designation in the U.S. That status, granted by the U.S. Food and Drug Administration (FDA),…

Pipeline Therapeutics will soon launch a Phase 1 clinical study to test PIPE-791, one of its candidate treatments for multiple sclerosis (MS), in healthy volunteers. The announcement follows a go-ahead from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND) application to initiate clinical…

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on ongoing trials of evobrutinib, Merck KGaA’s experimental BTK inhibitor for relapsing forms of multiple sclerosis (MS). The decision was based on two cases of patients in Phase 3 clinical trials of evobrutinib who were…

Tiziana Life Sciences plans to launch a Phase 2 clinical trial to investigate its foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS) in late 2023, the company announced. The decision follows a Type C meeting with the U.S. Food and Drug Administration (FDA), wherein…

The U.S. Food and Drug Administration (FDA) has cleared AB Science to initiate a Phase 3 clinical trial of its investigational treatment masitinib in people with progressive forms of multiple sclerosis (MS). The decision follows approvals in several European countries that will also host trial sites, including…

The U.S. Food and Drug Administration (FDA) has expanded the label for Botox (onabotulinumtoxinA) in adults for the treatment of upper limb spasticity — a common symptom of multiple sclerosis (MS) — to include eight more muscles. The new approval will allow Botox to be used to treat…

The U.S. Food and Drug Administration (FDA) has given the green light to a Phase 2 clinical trial that will assess the efficacy of using adult mesenchymal stem cells (MSCs) to treat the symptoms of mild to moderate multiple sclerosis (MS). The non-profit Hope Biosciences Stem Cell Research Foundation (HBSCRF),…