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The FDA has approved Merck’s Keytruda (pembrolizumab) for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation. Read More
Keytruda was approved earlier this month as a monotherapy for patients with unresectable or metastatic tumor mutational burden-high solid tumors. Read More
Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or efficacy. Read More
Myovant submitted a separate new drug application for relugolix last month for women with heavy menstrual bleeding associated with uterine fibroids. Read More