- The U.S. Food and Drug Administration (FDA) accepted to review Regeneron Pharmaceuticals (REGN +1.9%) and Sanofi's (SNY -0.2%) application seeking approval of Libtayo (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC).
- The FDA is expected to make a decision by Sept. 19.
- The supplemental Biologics License Application is backed by positive data from a phase 3 trial.
Sanofi-Regeneron's Libtayo combo accepted for review by FDA for lung cancer subtype
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Regeneron Pharmaceuticals, Inc. |