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The U.S. Court of Appeals for the Third Circuit upheld a Delaware federal district court’s decision to throw out an FTC lawsuit that sought to curb alleged misuse of citizen petitions to delay market entry of generic drugs. Read More
FDA Commissioner Scott Gottlieb on Wednesday made his agency’s case before a key House appropriations subcommittee as the lawmakers begin the process of developing next year’s budget. Read More
Commissioner Scott Gottlieb said the agency’s aim in the guidance is to “promote innovation in NRT by outlining a broader set of criteria that can serve as the basis for new approvals.” Read More
Pay-for-delay deals “hurt consumers twice,” by delaying the introduction of cheaper generics and by stifling competition among multiple generics companies, the bill’s sponsor said. Read More
The agency said it will limit the approved use of Uloric to certain patients who experience side effects or don’t see effective treatment from allopurinol. Read More
The FDA’s Oncologic Drugs Advisory Committee voted 8 to 5 on Tuesday in favor of delaying the approval of Karyopharm Therapeutics’ NDA for selinexor, a multiple myeloma treatment, pending the results of a Phase 3 trial. Read More