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, […]
FDA declares Wegovy® and Ozempic® shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses
All doses of the only real FDA-approved semaglutide medicines are being continuously shipped, meeting or exceeding expected U.S. demand FDA’s decision means that making or selling a knockoff compounded drug that is essentially a copy […]
Atreon Orthopedics Announces FDA 510(k) Clearance and Full Market Launch of BioCharge® Autobiologic Matrix for Rotator Cuff Repair
The BioCharge implant is the first-of-its-kind fully resorbable synthetic scaffold designed to supercharge tendon healing with a significantly simplified surgical technique DUBLIN, Ohio, Feb. 20, 2025 /PRNewswire/ — Atreon Orthopedics, LLC, a Columbus based innovator in […]
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 […]
