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)....
treatment News
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...
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...
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US. The FDA grants...
FORT WORTH, Texas — TFF Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced positive initial data from the Company’s ongoing Phase 2 trial of TFF VORI along with clinical data from the...
AUSTIN, Texas – TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today provided an update on the clinical development progress of its Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder products. Voriconazole...
NEW YORK, NY — TG Therapeutics, Inc. (NASDAQ: TGTX), announced that it has been awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI® (ublituximab-xiiy) to be the preferred agent listed on the VA National Formulary for Anti-CD20 Antibody indications for patients with relapsing forms of multiple sclerosis...