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March 29, 2024

FDA approves Gilead’s Vemlidy sNDA for paediatric HBV patients

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences’ supplemental new drug application (sNDA) for Vemlidy (tenofovir alafenamide) 25 mg tablets to treat chronic hepatitis B virus (HBV) in paediatric patients.

Vemlidy is now indicated for treating HBV infection in children aged six years and above weighing a minimum of 25kg with compensated liver disease. Credit: Drew Gilliam on Unsplash.