[Press release] FDA grants priority review of New Drug Application for Gilead’s once-daily HIV treatment of bictegravir plus lenacapavir

Gilead Sciences announced that the FDA has granted priority review to its New Drug Application for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN), an investigational once-daily single-tablet regimen for HIV treatment. The FDA has set a PDUFA action date of August 27, 2026. If approved, BIC/LEN aims to provide sustained virologic suppression for adults with HIV, especially those who are aging, have comorbidities, or have prior ARV resistance.

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