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Tiziana Life Sciences Granted FDA Breakthrough Approval for At-Home Intranasal Foralumab in Multiple Sclerosis Treatment

Tiziana Life Sciences, a biotechnology company specializing in innovative immunomodulation therapies, has reached a significant milestone in the treatment of multiple sclerosis. The U.S. Food and Drug Administration (FDA) has granted approval for multiple sclerosis patients to self-administer Intranasal Foralumab, a groundbreaking therapy developed by Tiziana Life Sciences.

Collaboratively developed and refined with the FDA, Delivery Device Training materials will ensure that patients receive proper training for using the nasal device. Intranasal Foralumab, a novel biologic therapy, has shown promising results in managing multiple sclerosis, and allowing patients to self-administer this treatment at home represents a substantial improvement in accessibility and convenience for individuals with this challenging condition.

Activated T cells play a vital role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor, reducing inflammation by modulating T cell function and suppressing effector features across various immune cell subsets. This effect has been demonstrated in patients with COVID, multiple sclerosis, and healthy subjects. The non-active SPMS intranasal Foralumab Phase 2 trial is expected to begin screening soon.

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