Tiziana Life Sciences granted FDA Fast Track Designation for foralumab

Tiziana Life Sciences announced the U.S. Food and Drug Administration, FDA, has granted Fast Track designation for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis. The Fast Track designation is a significant milestone for Tiziana Life Sciences, providing an expedited review process and increased interaction with the FDA. This designation is intended to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need. “We are thrilled to receive Fast Track designation from the FDA for intranasal foralumab for the treatment of Multiple Sclerosis,” said Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences. “This designation underscores the potential of foralumab to address critical unmet needs in the treatment of neurodegenerative diseases. We are committed to advancing this promising therapy as quickly as possible to benefit patients.”