FDA, HIV and Gilead Sciences

FDA sets June date for Gilead's twice-yearly HIV PrEP
Analysts at RBC Capital Markets have predicted twice-yearly lenacapavir could become a $2 billion product, and become a key component of Gilead's PrEP franchise as it tries to ward off a challenge from HIV market rival ViiV Healthcare, majority owned by GSK.
Gilead Gets FDA Priority Review of Twice-Yearly Shot to Prevent HIV
Gilead Sciences has won Food and Drug Administration priority review for its proposed lenacapavir twice-yearly shot to prevent HIV. Gilead on Tuesday said an FDA green light would make lenacapavir the first and only twice-yearly drug for the prevention of HIV as pre-exposure prophylaxis.
FDA Approves NDA for Gilead's new HIV Prevention Shot
Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving this drug a priority review and expects to make a decision by June 19, 2025,
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).
A new HIV prevention drug could get FDA approval this year
Preventing HIV infections could soon be as simple as two shots a year. Gilead announced on Tuesday that the Food and Drug Administration (FDA) has accepted its new drug applicatio
Gilead’s lenacapavir moves closer to FDA approval for HIV PrEP use
The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application (NDA) for lenacapavir and set a prescription drug user fee act (PDUFA) target action date of
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Urgent and accelerated delivery of HIV services is critical to end AIDS by 2030
PRESS RELEASE Urgent and accelerated delivery of HIV services is critical to end AIDS by 2030 Gujarat Chief Minister Shri ...
New paper-based device boosts HIV test accuracy from dried blood samples
In parts of the world where traveling to a clinic for routine blood tests is a financial and logistical challenge, HIV ...
Rolling Out1d
Drug abuse doubles your HIV risk, doctors warn
Understand how drug use increases HIV risk and learn about prevention strategies that save lives. Medical experts explain ...
Utah Public Radio23h
A breakthrough HIV drug was developed using Utah biochemistry research
An HIV drug was named “2024 Breakthrough of the Year” by Science Magazine. Biochemistry research from the University of Utah ...
MP reveals he's living with HIV and says that people should 'just get tested'
The latest MP to publicly reveal they are living with HIV says the stigma about the virus is putting straight people at risk.
Gilead Stock Rises 8% Post Q4 Earnings: Should You Buy or Sell?
GILD's strong HIV portfolio should maintain momentum for the company. The guidance for 2025 is impressive. We believe there ...
ABC News6d
What happens to the body when HIV drugs are stopped for millions of people
A generation has passed since the peak in AIDS-related deaths A generation has passed since the world saw the peak in AIDS-related deaths. Those deaths — agonizing, from diseases the body might ...
The Grio5d
This is what happens to the body when HIV drugs are stopped for millions of people
Now millions of people take drugs known as antiretrovirals that keep HIV from spreading in the body. Stopping those drugs lets the virus start multiplying in the body again, and it could become ...