NEW YORK, NY — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that dosing has commenced at the fourth clinical site in its ongoing Phase 2 trial evaluating intranasal foralumab...
treatment News
NEW YORK, NY — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS). This...
BOSTON, Mass. — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that its Phase 2 clinical trial evaluating intranasal foralumab in patients with amyotrophic lateral sclerosis (ALS) has been accepted for inclusion in the ALS MyMatch Program at the...
ST. LOUIS, MO – Each year, tuberculosis (TB) kills more people than any other infectious disease, falling out of the top spot only temporarily during the COVID-19 pandemic. Despite TB’s wide reach and some lost progress during the COVID-19 pandemic, researchers believe it is possible to eradicate TB through advances...
Paris, France – The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients. The target action date for the FDA decision is September...
BASEL, Switzerland – TOLREMO therapeutics AG (TOLREMO), today announced that their lead candidate, TT125-802, received two Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer (NSCLC). One Fast Track designation was granted for the treatment of patients with locally advanced or metastatic NSCLC...
San Diego, Calif. – The BIO Convention always highlights new regulatory developments, cutting edge technologies and the best new companies that are going change the face of healthcare in the near future, and 2024’s conference did not disappoint. The first of a series of CheckOrphan articles highlighting companies changing the...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the trade name, Tonmya™, for the company’s drug product candidate TNX-102 SL for the management of fibromyalgia. Tonmya...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Phase 3 RESILIENT study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint in the second of two positive Phase 3 clinical trials, significantly...