Gilead’s lenacapavir under priority review could revolutionise HIV PrEP
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application submissions for lenacapavir for human immunodeficiency virus (HIV) prevention. Lenacapavir was granted breakthrough therapy designation for HIV prevention by the FDA in October 2024 and will be reviewed by the FDA under priority review,
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
FDA Accepts 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,
FDA sets date for decision on twice-yearly shots to prevent HIV
The FDA has accepted Gilead Sciences’ new drug application for lenacapavir as a long-lasting injectable to prevent HIV infection and set a date of June 19 to decide on its approval, Gilead announced Tuesday.
US FDA accepts Gilead’s NDA for twice-yearly lenacapavir for HIV prevention under priority review
Foster City, California Thursday, February 20, 2025, 12:00 Hrs [IST]
Twice-Yearly Lenacapavir Gets Priority Review For HIV PrEP
The Food and Drug Administration (FDA) has accepted under Priority Review the New Drug Application (NDA) for lenacapavir, a long-acting HIV-1 capsid inhibitor, for the prevention of HIV as pre-exposure prophylaxis (PrEP).
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).
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.
Gilead announces FDA acceptance of lenacapavir NDA submissions
Gilead (GILD) announced that the FDA has accepted its new drug application submissions for lenacapavir, the company’s twice-yearly injectable
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
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New HIV therapy shows promise in Uganda
A new HIV drug, lenacapavir, appears highly effective against strains circulating in Uganda, according to a study led by ...
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New HIV therapy lenacapavir shows high efficacy in Ugandan population
A multi-national, multi-institutional study led by Weill Cornell Medicine investigators found little natural resistance to a ...
Drug therapy lenacapavir may effectively control HIV in Uganda
A multi-national, multi-institutional study led by Weill Cornell Medicine investigators found little natural resistance to a ...
Bay Area Reporter2d
Twice-yearly PrEP could be available this summer
Twice-yearly lenacapavir PrEP could be available as early as this summer pending federal Food and Drug Administration ...
Science Daily1d
New therapy may effectively control HIV in Uganda
A multi-national, multi-institutional study investigators found little natural resistance to a new HIV therapy called lenacapavir in a population of patients in Uganda.
The Pharma Letter2d
Lenacapavir PDUFA date set for June
US biotech Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application ...
Utah Public Radio3d
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 ...