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...