EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment options The multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for...
treatment News
SOUTH SAN FRANCISCO, Calif. — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, presented interim data from the ongoing RIDGE™-1 Phase 1b/2 clinical trial of TN-401 gene therapy at the...
FOSTER CITY, Calif. — Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to TERN-701, a novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Ph+ CML in the...
SOMERVILLE, Mass. — Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TSRA-196, its lead in vivo gene editing therapy for alpha-1 antitrypsin deficiency (AATD)....
SOMERVILLE, Mass. — Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to TSRA-196, its lead in vivo gene editing program. TSRA-196 is being jointly developed...
SOMERVILLE, Mass. — Tessera Therapeutics (“Tessera”), the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, is presenting updates across its in vivo genetic medicine programs for SCD and T cell therapies, including its proprietary delivery platform that enables extra-hepatic LNP delivery to hematopoietic stem cells (HSCs)...
GRAND RAPIDS, Mich. – Tetra Therapeutics, a wholly owned subsidiary of Shionogi & Co. Ltd., today announced positive topline results from its Phase 2 exploratory study in adult patients with Fragile X Syndrome (FXS). The study evaluated its lead candidate, BPN14770, a first-in-class phosphodiesterase‐4D (PDE4D) allosteric inhibitor. In this single-center,...
PARSIPPANY, N.J. and TEL AVIV, Israel — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of data from a real-world survey of patients taking AUSTEDO XR® (deutetrabenazine) extended-release tablets. Patients taking AUSTEDO XR reported increased social and emotional well-being as a...
PARSIPPANY, N.J., and TEL AVIV, Israel –– Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of new data from the ongoing, real-world IMPACT-TD Registry. The findings demonstrate that treatment with AUSTEDO (deutetrabenazine) tablets or AUSTEDO XR (deutetrabenazine) extended-release tablets for...
PARSIPPANY, N.J. — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Teva’s investigational therapy emrusolmin (TEV-56286) for the treatment of Multiple System Atrophy (MSA). Emrusolmin is part of a...