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The committee unanimously agreed that the company provided sufficient evidence that the drug reduced the risk of cardiovascular events in conjunction with statin therapy in adults with elevated triglyceride levels. Read More
HHS Secretary Alex Azar said the administration is looking to change the policy so that Americans pay even less for covered drugs than other developed countries. Read More
The FDA hit Florida stem-cell supplier RichSource Stem Cells with an untitled letter for unapproved claims relating to its RICHGEN stem cell product.
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The FDA on Friday issued a new draft guidance that would formalize its current process for issuing discretionary Certificates of Confidentiality for commercial sponsors that seek to prohibit disclosure of identifiable information about a research participant. Read More
Five former FDA Commissioners threw their support behind Stephen Hahn to lead the agency, in a letter to Senate leaders urging his confirmation. Read More