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...
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TIVDAK® is the first and only antibody-drug conjugate (ADC) approved for patients with advanced or recurrent cervical cancer in Japan Approval is based on results from the global Phase 3 innovaTV 301 trial, in which TIVDAK demonstrated superior overall survival compared to chemotherapy Rising cervical cancer incidence and mortality rates...
FREMONT, Calif. —Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced it has received, from Statera Biopharma, two investigational new drug applications (INDs) for its lead candidate, Entolimod™. The two INDs cover the use of Entolimod to treat acute radiation syndrome, including both hematopoietic (ARS-H) and gastrointestinal...
Meaningful Fatigue score reduction seen in study is a critically important quality of life (QoL) measure for Multiple Sclerosis patients. All patients experienced stabilization of Expanded Disability Status Scale (EDSS) scores. TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05). NEW YORK, NY — Tiziana Life Sciences,...
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...
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...
Tokyo, Japan – Chromosome 18q deletion (18q del) syndrome is a rare genetic condition disorder, affecting approximately 1 in 40,000 to 55,000 individuals, caused by the deletion of genetic material on the long arm of chromosome 18. This genetic anomaly disrupts normal growth and development, and critically, can impair 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...
ANDERSON — “Every day is so different,” said Amanda Pfeiffer of Anderson. Pfeiffer was referring to her infant son, Kohen, who lives with a condition known as epidermolysis bullosa. “Like right now, he can’t be out in the heat and humidity, because it makes him blister really easily. It’s an...