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The agency cited manufacturing concerns but did not question the safety and effectiveness of bulevirtide.
The new drug reduced HDV viral load and lowered liver enzyme levels in people with hepatitis B and D.
Hepcludex, formerly known as Myrcludex B, suppressed hepatitis B and hepatitis D virus replication in clinical trials.
Bulevirtide plus pegylated interferon shows promise for hard-to-treat coinfection.
A quick overview of our reporting on the 53rd International Liver Congress in Vienna
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