Gilead Sciences Secures FDA Approval for Yeztugo as HIV Prevention PrEP and Pursues Accelerated Regulatory Reviews Globally

Reuters
2025/07/14
<a href="https://laohu8.com/S/GILD">Gilead</a> Sciences Secures FDA Approval for Yeztugo as HIV Prevention PrEP and Pursues Accelerated Regulatory Reviews Globally

Gilead Sciences Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Yeztugo as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. This approval marks a significant step in HIV prevention efforts. Additionally, Gilead has submitted applications for marketing authorization and EU-M4all with the European Medicines Agency $(EMA)$ for the same medication, which are under expedited review. The company is also seeking regulatory approval for twice-yearly lenacapavir as PrEP in several countries, including Australia, Brazil, Canada, South Africa, and Switzerland, with plans for further filings in Argentina, Mexico, and Peru. This development aligns with Gilead's strategic partnership with The Global Fund to supply lenacapavir at no profit to reach up to two million people in supported countries over the next three years.

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 on July 14, 2025, and is solely responsible for the information contained therein.

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