FDA rejects Gilead’s bulevirtide for hepatitis D, compensated liver disease

The FDA issued a complete response letter to Gilead indicating it cannot approve the company’s new drug application that seeks approval of bulevirtide for chronic hepatitis D virus infection and compensated liver disease.In its letter, the FDA cited concerns over the manufacture and delivery of bulevirtide, a first-in-class investigational entry-inhibitor; however, no new studies to assess the safety and efficacy of the drug have been requested.“While we are disappointed with this outcome, we remain confident in the benefits bulevirtide could potentially bring to people livingRead More

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