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CAMBRIDGE, Mass. — Tisento Therapeutics today announced that the global Phase 2b PRIZM study is fully enrolled. PRIZM is evaluating zagociguat – a once-daily, oral investigational medicine – as a treatment for the rare mitochondrial disease MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes). The study enrolled 43 participants, and...
Primary Endpoint Met: Statistically significant reduction in heavy menstrual bleeding achieved in all dosage of Merigolix groups compared to placebo Broader Therapeutic Potential: Positive Phase 2 results in both uterine fibroids and endometriosis could place Merigolix as a strong best-in-class candidate for novel drug approval and global licensing opportunities Multi-Indication Development: Clinical trials...
SEONGNAM, South Korea — On Friday, 7 November (local time) at the Society for Immunotherapy of Cancer (SITC) 2025 annual meeting, Tiumbio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company dedicated to developing novel therapies for rare and intractable diseases, today shared the interim Phase II clinical data for its “first-in-class” Tosposertib...
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...
  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,...
BOSTON, Mass. — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana”), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces updated clinical data from its ongoing Expanded Access (“EA”) Program evaluating intranasal foralumab in 14 patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The...