FDA Approves Nubeqa for Non-metastatic Prostate Cancer

Today, the Food and Drug Administration (FDA) approved Nubeqa (darolutamide; Bayer and Orion Corporation), an androgen receptor inhibitor for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). FDA approval was based on the...

FDA Safety Alert: Xeljanz

The Food and Drug Administration (FDA) has issued a safety communication regarding risk of blood clots and of death with a 10 mg twice daily dose of Xeljanz/Xeljanz XR (tofacitinib; Pfizer Inc.). Xeljanz is a janus kinase inhibitor that was first approved in 2012 to...

FDA News Briefs for Thursday, July 25, 2019

These Food and Drug Administration (FDA) developments came in this week:First Nasal Glucagon Approved for Severe HypoglycemiaThe FDA has granted approval to Baqsimi (glucagon; Eli Lilly and Company), an anti-hypoglycemic agent for the treatment of severe hypoglycemia...