The Food and Drug Administration (FDA) approved a twice-yearly injection developed to prevent HIV. The first and only of its kind drug, manufactured by Gilead Sciences, will be sold under the name Yeztugo (lenacapavir). WATCH: #GileadNews: The FDA has approved our injectable HIV-1 prevention medication, making it the first and only twice-yearly #HIV prevention option in the U.S. This approval is helping to usher in the future of prevention as we work to help end the epidemic. https://t.co/wGacaduPRn pic.twitter.com/BqVToUqrtX — Gilead Sciences (@GileadSciences) June 18, 2025 Per Gilead Sciences: Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company’s injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. “This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.” The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012. However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed a form of PrEP. CDC data show that all populations in the U.S. are not yet using PrEP at rates that could end transmission of the virus at the population level, with particular gaps for women, Black/African American and Hispanic/Latino people, and people in the U.S. South. Data also show that barriers including adherence challenges, stigma and low awareness of existing PrEP options—by both healthcare providers and consumers—contribute to this low uptake of PrEP across multiple populations. The potential impact of this limited uptake, adherence and access is underscored by the fact that, in 2023, more than 100 people were diagnosed with HIV every day in the U.S. FDA Greenlights Twice-A-Year HIV Prevention Drughttps://t.co/wxILsohVki pic.twitter.com/bd1uXkjp2i — Forbes (@Forbes) June 18, 2025 From the Associated Press: While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take. “This really has the possibility of ending HIV transmission,” said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research. Condoms help guard against HIV infection if used properly but what’s called PrEP — regularly using preventive medicines such as the daily pills or a different shot given every two months — is increasingly important. Lenacapavir’s six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills. But upheaval in U.S. healthcare — including cuts to public health agencies and Medicaid — and slashing of American foreign aid to fight HIV are clouding the prospects. Millett said “gaping holes in the system” in the U.S. and globally “are going to make it difficult for us to make sure we not only get lenacapavir into people’s bodies but make sure they come back” twice a year to keep up their protection. Gilead’s drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It’s given as two injections under the skin of the abdomen, leaving a small “depot” of medication to slowly absorb into the body. People must test negative for HIV before getting their twice-a-year dose, Gilead warned. It only prevents HIV transmission — it doesn’t block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain.

The Justice Department sued Kentucky Gov. Andy Beshear and state officials for a policy the Trump administration says unlawfully allows illegal immigrants living in the Bluegrass State access to in-state college tuition. In a lawsuit filed in the Lexington-based Eastern District federal court, the Trump administration alleges the regulation unconstitutionally discriminates against American citizens. “No state can be allowed to treat Americans like second-class citizens in their own country by offering financial benefits to illegal aliens,” Attorney General Pam Bondi said, according to Fox News. DOJ Sues Kentucky Democrat Gov. Andy Beshear for Offering Reduced In-State Tuition to Illegal Aliens https://t.co/7WcwcLgUT4 — Steve Ferguson (@lsferguson) June 19, 2025 Fox News reports: When reached for comment, a representative for Democratic Gov. Andy Beshear said he had no role in creating the policy and that it is enforced by the Kentucky Council on Postsecondary Education (KCPE) which is an independent agency. “We haven’t been served with this lawsuit and had no advance notice, nor any prior discussion with the Department of Justice about it,” Beshear spokesperson Crystal Staley told Fox News Digital. Staley said the regulation was issued “before 2010” and that KCPE, not Beshear, has sole authority to determine tuition-related residency requirements. “The governor has no authority to alter CPE’s regulations and should not be a party to the lawsuit.” Melissa Young, a KCPE spokesperson, said the agency just found out about the lawsuit on Tuesday morning and that they are not prepared to offer detailed comment. “This unconstitutional regulation turns our universities into sanctuary cities, costing Kentuckians an estimated $5 million annually to benefit hundreds of illegal aliens—while denying the same opportunity to out-of-state U.S. citizens,” Kentucky state Rep. T.J. Roberts said. “I introduced HB 352 to BAN in-state tuition for illegals and stop Kentucky Universities from harboring illegals. Thank you to @tichenor4ky and the Kentucky Student Rights Coalition for fighting for this bill. While it didn’t make it across the finish line, we sent a message and WASHINGTON DC HEARD US LOUD AND CLEAR!” he continued. “Now, the Trump Administration and the Department of Justice have stepped in with a federal lawsuit filed yesterday against Beshear and the Kentucky Council on Postsecondary Education, validating the fight I took on right after I got elected,” he added. I Exposed Beshear’s Tuition Handouts to Illegal Migrants – Now the Trump Administration is Suing Beshear to put an end to it! Back in November, I was the one who first exposed the outrageous policy under Governor Andy Beshear’s regime that forces Kentucky taxpayers to… pic.twitter.com/Pn1NMLNqSd — TJ Roberts (@realTJRoberts) June 18, 2025 Per WHAS 11: The U.S. Justice Department’s lawsuit says the regulation violates federal immigration law by enabling undocumented students to qualify for the lower tuition rate at Kentucky’s public colleges and universities, while American citizens from other states pay higher tuition to attend the same schools. “Federal law prohibits aliens not lawfully present in the United States from getting in-state tuition benefits that are denied to out-of-state U.S. citizens. There are no exceptions,” the suit said. The lawsuit, filed Tuesday in a federal court in Kentucky, follows a similar action by Trump’s administration in another red state as part of its efforts to crack down on immigration. A federal judge blocked a Texas law that had given college students without legal residency access to reduced in-state tuition. That order only applied to Texas but was seen as an opening for conservatives to challenge similar laws in two dozen states. Such laws were intended to help “Dreamers,” or young adults without legal status, to be eligible for in-state tuition if they meet certain residency criteria. “The Department of Justice just won on this exact issue in Texas, and we look forward to fighting in Kentucky to protect the rights of American citizens,” Attorney General Pam Bondi said in a statement. The lawsuits in both states follow recent executive orders signed by Trump designed to stop any state or local laws or regulations the administration feels discriminate against legal residents.

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