us food & drug administration

U.S. Food & Drug Administration News: FDA approves first treatment for advanced form of the second most common skin cancer

SILVER SPRING, MD – The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.  This is the first FDA approval of a drug specifically for … Continue reading U.S. Food & Drug Administration News: FDA approves first treatment for advanced form of the second most common skin cancer

U.S. Food & Drug Administration News: FDA provides update on its ongoing investigation into valsartan products

WASHINGTON – The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recall of several drug products containing the active pharmaceutical ingredient (API) valsartan, used to treat high blood pressure and heart failure. The FDA’s latest testing of products shows an additional unexpected impurity in three … Continue reading U.S. Food & Drug Administration News: FDA provides update on its ongoing investigation into valsartan products