FDA Accepts New Drug Application For Investigational Compound Dapagliflozin For The Treatment Of Type 2 Diabetes
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for dapagliflozin, an investigational compound for the treatment of adults with type 2 diabetes mellitus. A Marketing Authorisation Application (MAA) for dapagliflozin has also been validated by the European Medicines ...

Medtronic resolves FDA warnings over 2 facilities
FDA lifts warnings against 2 Medtronic facilities, clearing way for new product approvals