SteadyMed Ltd.

The US FDA issued decisions on two new drug applications combining an on-body infusion device and an established drug last week. While the decisions went different ways – Supernus Pharmaceuticals, In

The US FDA’s oncology divisions continue to issue fast approvals, both under the Real-Time Oncology Review pilot program and in response to pressures caused by the coronavirus pandemic. This week, Me

A new breakthrough-designated formulation of an old chemotherapy drug for use in urothelial cancer, a chemo-free two-drug regimen for certain colorectal cancer patients, and a next-generation quadriva

The US Food and Drug Administration got right back into the novel drug approval game after a week off, giving its go-ahead to Ardelyx Inc. 's Ibsrela (tenapanor) for the treatment of irritable bowel