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  1. 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 …

  2. LIBTAYO® (cemiplimab-rwlc) | Official HCP Website

    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 …

  3. Covering Every FDA Oncology Approval From October 2025

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

  4. October 2025: A Look at FDA Oncology Approvals and Designations

    4 days ago · October 2025 saw key FDA approvals and designations, expanding treatment options for solid tumors and hematologic malignancies. New combination therapies and …

  5. Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and …

    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 …

  6. FDA Approval of Cemiplimab: A New Era for High-Risk CSCC Treatment

    Oct 28, 2025 · In a significant step forward for skin cancer management, the U.S. Food and Drug Administration (FDA) has approved cemiplimab-rwlc (Libtayo) as an adjuvant treatment for …

  7. Cemiplimab Gains FDA Approval for Adjuvant High-Risk CSCC

    Oct 11, 2025 · The FDA has approved adjuvant cemiplimab (Libtayo) for adults with high-risk cutaneous squamous-cell carcinoma after surgery and radiation.

  8. FDA Approves Libtayo for Adjuvant Treatment of High-Risk CSCC

    Oct 9, 2025 · The FDA has approved Libtayo for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.

  9. Libtayo (cemiplimab-rwlc) FDA Approval History - Drugs.com

    Oct 9, 2025 · Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of cutaneous squamous cell carcinoma (CSCC), basal cell …

  10. FDA approves Libtayo (cemiplimab-rwlc) as first and only treatment

    Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only treatment specifically approved and …