MELBOURNE, Australia — Telix Pharmaceuticals Limited (ASX: TLX) today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET). The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using...
treatment News
MELBOURNE, Australia — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces presentations from the Company’s carbonic anhydrase IX (CAIX) targeting kidney and bladder cancer programs at the 38th Annual European Association of Urology (EAU) Congress to be held in Milan from 10 – 13 March 2023. Further data from...
ANDOVER, Mass. — TellBio, Inc., a development-stage medical technology company focused on revolutionizing the detection of cancer metastasis through its unique and proprietary circulating tumor cell (CTC) technology, the TellDx CTC System, announces the publication of data that shows the promise of CTCs as a prognostic biomarker for patients with...
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,...
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...
NEW YORK, – TG Therapeutics, Inc. (NASDAQ: TGTX), announced the completion of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQTM (umbralisib) , the Company’s once-daily, oral, inhibitor...
BRIDGEWATER, NJ – Tharimmune, Inc. (NASDAQ:THAR), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology announced today the first patient dosed in the Company’s Phase 1 clinical trial with TH104, utilizing a proprietary oral thin film. TH104 is a proprietary transmucosal buccal film embedded with...