FDA approves cemiplimab-rwlc for adjuvant treatment of …
On October 8, 2025, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals Inc.) for the adjuvant treatment of adults with cutaneous …
FDA Approves Cemiplimab for Adjuvant Cutaneous Squamous …
Oct 8, 2025 · The US FDA has approved the supplemental biologics license application (sBLA) for cemiplimab-rwlc (Libtayo) as adjuvant treatment in adults with high-risk cutaneous squamous …
Libtayo (cemiplimab-rwlc) FDA Approval History - Drugs.com
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 …
FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC
Oct 9, 2025 · Findings showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo. The Food and Drug Administration (FDA) has approved Libtayo …
FDA Approves Libtayo for Immunotherapy for Adjuvant Treatment …
Oct 9, 2025 · FDA approved of Regeneron Pharmaceutical’s Libtayo (cemiplimab-rwlc)as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) who …
FDA Approves Libtayo as First Adjuvant Immunotherapy for High …
Oct 9, 2025 · The FDA has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first and only immunotherapy for the adjuvant treatment of cutaneous squamous cell carcinoma …
FDA Approves Cemiplimab as Adjuvant Treatment for …
Oct 8, 2025 · Cemiplimab's approval is supported by findings from the C-POST clinical trial. The FDA approved cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals) for the adjuvant …
REGN Gets EC Nod for Libtayo Label Expansion, FDA Clears …
Nov 20, 2025 · Regeneron gains EC approval to expand Libtayo's use in high-risk CSCC. The FDA approves Eylea HD the treatment of patients with macular edema following retinal vein …
FDA Approves Cemiplimab as First, Only Adjuvant …
Oct 8, 2025 · Cemiplimab is the first immunotherapy approved for adjuvant treatment in CSCC, offering a new option for patients at high risk of recurrence.
FDA approves Regeneron’s Libtayo for high-risk CSCC post …
The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ fully human monoclonal antibody Libtayo(cemiplimab-rwlc) as an adjuvant …