– If approved, lenacapavir would be the first and only twice-yearly HIV prevention choice –
– FDA to review applications under priority review, with a PDUFA date of June 19, 2025 –
– Gilead also recently submitted applications for lenacapavir for PrEP to the European Medicines Agency that will be reviewed under Accelerated Assessment review timeline –
Read the full company press release here.
SEE ALSO:
- POZ: Gilead aims to launch twice-yearly PrEP this summer
- Healio: FDA sets date for decision on twice-yearly shots to prevent HIV
Source : Gilead Sciences, Inc.
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