On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous …

Oct 8, 2025 · The FDA evaluated Libtayo under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of …

Nov 3, 2025 · FDA Approves Libtayo for High-Risk Cutaneous Squamous Cell Carcinoma The FDA has approved Libtayo (cemiplimab-rwlc) for adjuvant treatment in adults with cutaneous …

Oct 8, 2025 · Regeneron (NASDAQ: REGN) announced FDA approval of Libtayo (cemiplimab-rwlc) as the first and only immunotherapy for adjuvant treatment of cutaneous squamous cell …

LIBTAYO® (cemiplimab-rwlc) is a prescription medicine indicated for the treatment of adult patients with advanced NSCLC, CSCC, BCC, and as an adjuvant treatment for high-risk CSCC. …

Oct 8, 2025 · TARRYTOWN, N.Y. - The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals’ (NASDAQ:REGN) Libtayo (cemiplimab-rwlc) as an adjuvant …

Oct 15, 2025 · “This approval provides patients with CSCC at high risk of disease recurrence following surgery and radiation a much-needed option, as Libtayo is the only immunotherapy to …

Oct 9, 2025 · Libtayo FDA Approval History Last updated by Judith Stewart, BPharm on Oct 9, 2025. FDA Approved: Yes (First approved September 28, 2018) Brand name: Libtayo Generic …

What is LIBTAYO? LIBTAYO is the first medicine approved by the Food and Drug Administration (FDA) to treat CSCC that has spread or cannot be cured by surgery or radiation. LIBTAYO is a …

Oct 9, 2025 · The FDA evaluated Libtayo under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of …