The report was prompted by the FDA's 2021 approval of the ... told MedPage Today. "Eteplirsen was granted approval in 2016 and after 9 years, the drug's manufacturer still has not provided ...
Vertex Pharmaceuticals on Thursday won approval from the Food and Drug Administration for a non-opioid pain drug, clearing ...
But it did not concur with the OIG’s other suggestion that it should define specific factors that would require the FDA’s accelerated approval council to advise on certain drug applications.
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