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The expanded indication was supported by data from a Phase 2 clinical trial.
April 1, 2024
By: Charlie Sternberg
Associate Editor
The U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Gilead Sciences’ Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. Vemlidy is a targeted prodrug of tenofovir that was approved by the FDA in 2016 as a once-daily treatment for adults with chronic HBV infection with comp...
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