New indication approximately triples eligible patient population, allowing Pluvicto® to be used after one androgen receptor pathway inhibitor (ARPI) and now before chemotherapy Pluvicto significantly reduced risk of progression or death by 59% and more […]
Tag: FDA Approval
Viva Biotech’s Wholly-Owned Subsidiary Langhua Pharmaceutical Successfully Passes U.S. FDA On-Site Inspection
SHANGHAI, March 28, 2025 /PRNewswire/ — Zhejiang Langhua Pharmaceutical Co., Ltd. (“Langhua Pharmaceutical”), a wholly-owned subsidiary of Viva Biotech Holdings (“Viva Biotech”), underwent a cGMP (Current Good Manufacturing Practices) on-site inspection by the U.S. Food […]
Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance
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 […]
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 […]
