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The FDA has granted orphan drug designation to Berkeley, Calif., drugmaker Xoma’s investigational treatment for congenital hyperinsulinism, a life-threatening disease that causes the body to produce excessive amounts of insulin. Read More
Generics industry groups told FDA officials during a public meeting Monday that review times and approvals of generic drugs have slipped significantly since implementation of the Generic Drug User Fee Act, and they called for major changes when the program is reauthorized in fiscal 2018. Read More
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
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