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Fri.Apr 26, 2024

fda-labelling

FDA Approves Label Update for Biktarvy as Treatment of HIV in Pregnant Adults

Pharmacy Times

APRIL 26, 2024

The approval is based on data from Study 5310, evaluating the pharmacokinetics, safety, and efficacy of Biktarvy (Gilead Sciences Inc) in pregnant individuals.

Labelling

123

Labelling FDA

123

FDA Approves Label Update for Gilead’s Biktarvy to Include Pregnant Adults With HIV

PharmExec

APRIL 26, 2024

Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.

Labelling

Labelling FDA

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