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FDA grants priority review for Gilead bictegravir-lenacapavir HIV pill NDA

PUBT·04/29/2026 12:32:26
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FDA grants priority review for Gilead bictegravir-lenacapavir HIV pill NDA
  • FDA accepted Gilead NDA for investigational once-daily HIV single-tablet regimen bictegravir 75 mg/lenacapavir 50 mg for virologically suppressed adults.
  • Agency granted priority review with PDUFA action date set for Aug. 27, 2026.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Gilead Sciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260427182040) on April 29, 2026, and is solely responsible for the information contained therein.