Top Regulatory News Stories – Week Ending June 15, 2018

The FDA granted accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced, PD-L1–positive cervical cancer with disease progression on or after chemotherapy. Keytruda was previously approved for several other oncology indications including metastatic non-small cell lung cancer, advanced melanoma, recurrent or metastatic head and neck squamous cell carcinoma, metastatic urothelial carcinoma,[…]