sBLA

September 25, 2018September 25, 2018

FDA Grants Priority Review to Keytruda as First-line Therapy for Advanced NSCLC

News

The U.S. Food and Drug Administration (FDA) has agreed to review Merck‘s application seeking the extension of Keytruda (pembrolizumab) as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC). The ... Read more

July 11, 2018July 11, 2018

FDA Grants Priority Review to Keytruda-Chemo Combo for Metastatic NSCLC

News

The U.S. Food and Drug Administration (FDA) has agreed to review a combination of Keytruda (pembrolizumab) and chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC). Merck’s supplemental ... Read more

October 18, 2017

FDA Grants Priority Review to Application for Opdivo as Treatment for Resected Advanced Melanoma

News

The U.S. Food and Drug Administration has accepted Bristol-Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) as a treatment for resected high-risk advanced melanoma. The agency also ... Read more