COPENHAGEN, Denmark — Genmab A/S (Nasdaq: GMAB) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic...
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...
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...
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., 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...
CHATHAM, N.J. — Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-2900 (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-enhanced formulation...
Chatham, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver an oral presentation and the Company will present a poster at the 5th International Congress on Controversies in Fibromyalgia being held March 30-31, 2023...
Chatham, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced that Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, will deliver a presentation at the Rare Disease Innovation and Partnership Summit, which will be held as a hybrid event in Philadelphia, Pa.,...
CHATHAM, N.J. — Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP) , a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of additional safety and tolerability data from RESILIENT, the second positive Phase 3 study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of...