FDA News

The FDA has issued a letter about a possible risk of increased mortality among patients with a type of arterial disease who have paclitaxel-coated implants.

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for olaparib (Lynparza) tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

The FDA has approved a new agent for the treatment of severe hepatic veno-occlusive disease, a rare but often fatal complication in patients who receive chemotherapy and hematopoietic stem cell transplantation.