Tiziana Life Sciences announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis, na-SPMS, to the U.S. Food and Drug Administration, FDA. “Fast track is designed to expedite the review of drugs in development to treat serious conditions for which there are limited or no therapies,” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences. “The progressive nature of na-SPMS and lack of FDA-approved therapies for this disease aligns with the Food and Drug Administration’s criteria for Fast Track Designation. The increased interaction and partnership with the FDA afforded by this designation would be a tremendous asset to our foralumab development program, if granted,” he added.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on TLSA:
- Tiziana Reports Progress in MS Treatment Trials
- Tiziana Life Sciences Announces Six-Month Qualitative Improvement in Neuroimaging in 80% of Multiple Sclerosis Patients Receiving Intranasal Foralumab
- Tiziana Life Sciences announces results for na-SPMS patients enrolled in EAP
- Tiziana Seeks ALS Trial Funding for Foralumab
- Tiziana Life Sciences submits grant application to ALS Association