FDA accepts Bristol-Myers’ application for Opdivo+Yervoy regimen for advanced melanoma
The agency has granted priority review for this sBLA and is expected to respond by 30 September. The new application is based on data from CheckMate -069, the
Amgen has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Repatha (evolocumab) supporting its broader use prior to a first heart attack or stroke.
This is the first combination of BRAF/MEK inhibitors to demonstrate a statistically significant overall survival benefit for this patient population in two Phase III studies. Results are being
MM-398 is a new, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. The filing follows the recent submissions of NDA and marketing authorization application (MAA) by its