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Gilead's Descovy May Have Problem Getting HIV Prevention Indication In Cisgender Women

 
• By Sue Sutter

Descovy demonstrated noninferiority to Truvada in men and transgender women who have sex with men, but pharmacokinetic data do not support a demonstration of pre-exposure prophylaxis efficacy in cisgender women, US FDA says in advisory committee briefing document.

Aids red ribbon on woman's hand support for World aids day and national HIV/AIDS and aging awareness month concept - Image
Gilead is seeking to expand the labeling of Descovy to include HIV pre-exposure prophylaxsis. • Source: Shutterstock

The US Food and Drug Administration is asking its Antimicrobial Drugs Advisory Committee whether Gilead Sciences Inc. has more work to do before Descovy (emtricitabine/tenofovir alafenamide) can be approved for use as HIV pre-exposure prophylaxis in cisgender women.

In briefing document released ahead of a 7 August meeting, the agency suggests Gilead’s pharmacokinetic data are insufficient to...

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Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
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EU CHMP Opinions And MAA Updates

 
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