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Israeli drugmaker Teva will pay $24 million to settle a pay-for-delay lawsuit over its generic version of AstraZeneca’s heartburn relief drug Nexium. Read More
The agency will let drugmakers create clinical trials that allow a higher tolerance for risk, depending on a patient’s age and condition severity. Read More
PhRMA and the Medical Information Working Group want the FDA to clarify its rules around manufacturer promotion of off-label drug use and are using a small drugmaker’s lawsuit against the agency to press their case. Read More
The FDA has approved an sNDA for Novartis’ Promacta for the treatment of children six years and older with the chronic immune thrombocytopenia who have had a poor response to corticosteroids, immunoglobulins or spleen removal. Read More
Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More
An FDA associate commissioner and five associates are pushing for greater transparency around complete response letters issued to drugmakers when marketing applications are denied. Read More
A citizens advocacy group is accusing the FDA of wrongly expanding the indication of Vanda Pharmaceuticals’ sleep disorder drug Hetlioz by labeling it for use in sighted people. Read More
The U.S. Food and Drug Administration plans to provide guidance by year’s end on naming biosimilars, potentially ending much of the confusion over how the products will be labeled and tracked. Read More