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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