Sanofi flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

Roche reports breakthrough phase III results for investigational multiple sclerosis drug

Fenebrutinib targets cells in the immune system known as B cells and microglia

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024

Multiple sclerosis market to generate sales of $29.8 billion by 2030, forecasts GlobalData

Several late-stage pipeline products have the potential to address some of these unmet needs

Biogen and MedRhythms partner for digital therapeutic targeting the treatment of gait deficits in multiple sclerosis

The investigational prescription digital therapeutic uses a combination of sensors, software, and music based on Rhythmic Auditory Stimulation (RAS)

Roche’s 8-year safety data of Ocrevus shows reduced risk in multiple sclerosis patients

New safety data show a consistent benefit-risk profile across all Ocrevus clinical trials

Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial

Lucid-MS represents a potential breakthrough in the treatment of multiple sclerosis

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients