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The FDA released a draft guidance for oncology drug developers on submitting initial pediatric study plans (iPSPs) after new requirements go into effect on August 18. Read More
The U.S. Supreme Court this week opted not to take up a patent suit between Vanda Pharmaceuticals and generic drugmaker Hikma Pharmaceuticals over Vanda’s schizophrenia treatment Fanapt (iloperidone). Read More
Republicans on the House Energy and Commerce Committee on Tuesday revived their investigation into the role three drugmakers played in the opioid crisis, pressing Insys, Mallinckrodt and Purdue Pharma for more details. Read More