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The FDA’s ad police warned a Campbell, Calif.-based company to stop claiming that its prescription diet pill can help patients lose weight three times faster than diet and exercise alone. Read More
Drug sponsors should “be careful” to make sure they’re properly screening treatments for nonalcoholic steatohepatitis (NASH) compensated cirrhosis patients for Phase 3 clinical trials , the FDA says in a new draft guidance issued Friday. Read More
Insys Therapeutics bribed doctors to prescribe its fentanyl spray, the company admitted as part of a $225 million settlement with the U.S. government, the Department of Justice announced. Read More
Drug sponsors should think about loosening up their exclusion criteria—especially when recruiting for later stage trials, the FDA says in new draft guidance document published Thursday. Read More
A panel of experts on Thursday urged the FDA to approve a three-drug cocktail that backers say has produced miraculous results in patients with a particularly nasty form of tuberculosis. Read More
Including patients co-infected with HBV/HCV in an immuno-oncology drug trial has its own complexities because of the “known interaction” between the two viruses during co-infection, Merck said. Read More