It's the second for this cancer drug in two weeks.
The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.
The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.
Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.
The FDA granted Priority Review for consideration of Avastin for some cervical-cancer patients.
An advocacy group alleges that Shire's decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.
The House Energy and Commerce Committee is putting two health-related bills to vote Monday. One covers new sunscreen ingredients, the other muscular dystrophy research.
In the latest chapter in the Sovaldi pricing saga, Senators Ron Wyden and Charles Grassley urge Gilead to clarify Sovaldi sticker shock.
Bristol-Myers Squibb is moving forward with its FDA filing of PD-1 Opdivo (formerly known as nivolumab) for patients with advanced melanoma who have been previously treated with the BMS drug Yervoy.
The FDA began its drug review at a median time of 103 days sooner than the EMA. Being first, researchers found, often resulted in quicker approval.