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Gilead Granted Expanded Marketing Authorization For Biktarvy In The European Union

Gilead Sciences, Inc. (GILD) announced the European Commission has authorized
a new low-dose tablet dosage form of Biktarvy and an extension of the indication for Biktarvy to treat HIV infection in virologically suppressed children who are at least two years of age and weigh at least 14 kg. The company noted that the authorization is the first pediatric approval for Biktarvy in the European Union.

The authorization of an extended indication and line extension for Biktarvy for the treatment of HIV in children at least two years of age and weighing at least 14 kg is based on an open-label study.

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