The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component SALT LAKE CITY, Feb. 21, 2025 /PRNewswire/ — Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the “Company” or “Co-Dx”), a […]
Tag: FDA Approval
FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
SILVER SPRING, Md., Feb. 21, 2025 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, […]
Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA
SYDNEY, Feb. 19, 2025 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is […]
Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response […]
RiboX Therapeutics Announces FDA Clearance for IND Application of RXRG001, the First Circular RNA Therapy for the Treatment of Radiation-Induced Xerostomia and Hyposalivation
PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ — RiboX Therapeutics Ltd. (RiboX), a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, announced that the US Food and Drug Administration (FDA) has cleared […]
