We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is requesting all NDA and ANDA holders to submit a one-time, written status report to the agency after reviewing the information published in the Orange Book. Read More
The trial results showed the combinations did not significantly increase the risk of asthma-related hospitalizations, intubations or asthma-related deaths. Read More
Boehringer Ingelheim agreed to pay $13.5 million to all 50 states and the District of Columbia to settle a lawsuit alleging the company promoted unapproved uses of prescription drugs and engaged in deceptive marketing. Read More
The FDA removed its Boxed Warning regarding asthma-related death from the labels of medicines containing long-acting beta agonists in combination with inhaled corticosteroids, following postmarket studies of possible side effects. Read More
The French Competition Authority fined Johnson & Johnson €25 million ($27 million) for delaying market access to generic copies of its painkiller Durogesic, a fentanyl-based patch for treatment of chronic and severe pain. Read More
Sandoz triumphed over Amgen in a biosimilar patent infringement case that went from a Northern California federal court, up the ladder to the Supreme Court and back down again — following victories in both the district court and the Federal Circuit Court of Appeals this past week. Read More
An HHS audit of the Medicaid drug rebate program found hundreds of misclassifications by manufacturers — which may have led to more than $1.3 billion in lost rebates payable to the federal government over the past five years. Read More