LEE011 (ribociclib, a selective cyclin dependent kinase inhibitor developed by Novartis, was granted Priority Review by FDA. FDA also accepted Novartis’s new Drug Application for filing as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with letrozole. The NDA is based on...
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
