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Gilead Sciences Receives FDA Approval for Updated Label of Biktarvy
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Gilead Sciences Receives FDA Approval for Updated Label of Biktarvy
Apr 26, 2024 6:31 AM

09:14 AM EDT, 04/26/2024 (MT Newswires) -- Gilead Sciences ( GILD ) said Friday that the US Food and Drug Administration has approved an updated label for its antiviral pill Biktarvy in virologically suppressed pregnant adults with human immunodeficiency virus 1, or HIV-1.

The company said the label now includes additional data from a phase 1b study of Biktarvy which showed all participants maintained viral suppression during pregnancy, at delivery, and through week 18 postpartum. The study also showed no new safety concerns associated with Biktarvy use during pregnancy and postpartum, Gilead added.

Gilead said there is no cure for HIV or AIDS.

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