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FDA Approves First-Ever Injectable to Prevent HIV
The Food & Drug Administration (FDA) approved a new drug Monday that will allow patients to ditch the daily pill and receive treatment every two months. The drug, named Apretude, is being considered the first long-acting injectable medication for use as pre-exposure prevention, or PrEP, against HIV.
“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, said in a statement. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”
According to the U.S. Centers for Disease Control and Prevention (CDC), notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25 percent of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3 percent in 2015. However, there remains significant room for improvement.
PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication. Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option will increase PrEP uptake and adherence in these groups.
The FDA tested the safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized, double-blind trials that compared Apretude to Truvada, a once daily oral medication for HIV PrEP. Trial 1 included HIV-uninfected men and transgender women who have sex with men and have high-risk behavior for HIV infection. Trial 2 included uninfected cisgender women at risk of acquiring HIV.
Participants who took Apretude started the trial with cabotegravir (oral, 30 mg tablet) and a placebo daily for up to five weeks, followed by Apretude 600mg injection at months one and two, then every two months thereafter and a daily placebo tablet.
Participants who took Truvada started the trial taking oral Truvada and placebo daily for up to five weeks, followed by oral Truvada daily and placebo intramuscular injection at months one and two and every two months thereafter.
Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.
Apretude has been granted a Priority Review and Breakthrough Therapy designation. The FDA granted the approval of Apretude to ViiV Healthcare, which is majority owned by GlaxoSmithKline.
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Maine Democratic U.S. Senate nominee Graham Platner is under fire after releasing a video declaring that new allegations against him are false, yet he is “taking time to reflect” on a path forward.
Politico on Monday afternoon reported that a woman who dated Platner, Jenny Racicot, “says he forced her to have sex with him nearly five years ago despite her repeated objections, an allegation Platner denies.”
“Racicot said she had an on-and-off relationship with Platner,” Politico reported, “for more than two years before he entered her rural Maine home uninvited one night in late 2021, deeply intoxicated, and forced himself on her while she repeatedly told him to stop. She said she cut off contact with him after telling him the encounter was not consensual.”
In a video posted to social media eleven minutes after the Politico story dropped, Platner says, “I wanted to directly address the troubling, serious, and false allegations against me. Any accusation of nonconsensual behavior is categorically false.”
He said he and his supporters “were united in a love of Maine, a belief that our politics must change, in a focus on defeating Susan Collins.”
“So, regardless of the inaccuracy of the reporting, but mindful the political reality will inflict, we are taking the time to reflect on the best path forward for the state that I love, the people that I love, the movement I belong to, and the goal of defeating Susan Collins.”
“Those were the goals when we launched this campaign. And they remain my goals today.”
“Throughout it all, you never turned your back on me. And I will not turn my back on you now. Every one of you deserves to see that vision come to fruition and see Susan Collins defeated. And we will use every tool at our disposal to do so.”
The Bulwark’s Tim Miller, a political commentator who served as the communications director for the Jeb Bush 2016 presidential campaign, blasted Platner.
“I’m sorry but ‘we are taking time to reflect on the best path forward’ is not an option on the table,” Miller wrote. “Either it’s false and you campaign with vigor or it’s true and you get out / apologize to everyone you let down.”
Journalist Ryan Grim, commenting on Platner’s video, noted that Platner “strongly suggests he is considering dropping out. Already Troy Jackson and Chellie Pingree, both gubernatorial candidates, are being kicked around in Maine circles as potential replacements.”
Several others, including Puck News’ Peter Hamby, predicted Platner will be dropping out.
Platner had postponed several campaign events before the Politico story was published.
— Graham Platner for Senate (@grahamformaine) July 6, 2026
President Donald Trump is facing backlash after posting a video of children — including showing their unblurred faces — graduating from kindergarten, with some of the girls purportedly wearing hijabs.
“President Trump posted a captionless video of graduating kindergarteners on Truth Social on Monday, goading his supporters into verbally attacking little children simply for being Muslim,” The New Republic reported. “The clip is from Gateway STEM Academy, a majority-Black K-8 public charter school in St. Paul, Minnesota. It shows about 21 children in caps and gowns on stage singing a song together. Most of the girls are wearing hijabs.”
The original post of the video which Trump reposted reads: “Public school in St. Paul, Minnesota. Every girl is in a hijab … in kindergarten.”
Trump did not add any comments. TNR called the post “Islamophobic, weird, and creepy,” while noting that the comments section of Trump’s post was filled with calls “by racist, xenophobic MAGA supporters” to “deport the children and ban hijabs.”
TNR also noted that it “should come as no surprise that Trump isn’t above attacking children who just learned how to read, but this post is still particularly discomforting—and will certainly contribute to the already potent level of anti-Muslim sentiment in the U.S. and in Minnesota.”
Critics blasted Trump.
“There is something deeply unsettling about the president of the United States—the most powerful person in the world—going after kindergarten schoolchildren in Minnesota because they wore hijabs, as Trump has done this morning on his website,” The Bulwark’s Sam Stein wrote.
One social media commentator wrote, “Trump posted an unblurred video of more than a dozen Muslim kindergartners to Truth Social, exposing the children’s faces while targeting them for their religion.”
Another added, “Trump is a bigot. The president took to Truth Social to attack kindergarteners in hijabs. These are little kids. The president isn’t just a bigot, he’s also a coward.”
The original video was posted to the X social media platform in June.
U.S. Rep. Nancy Mace (R-SC) at the time commented, “If you are in a public school in America, you should be speaking english.”
Image via Reuters
President Donald Trump’s apparent efforts to delay releasing the $5.8 million civil judgment to E. Jean Carroll are being met with a warning by the journalist’s legal team, who suggest there could be a legal maneuver for Trump to employ to forgo paying the judgment in either of the two cases he lost.
According to The Guardian, on July 4, U.S. District Judge Lewis Kaplan ordered Trump to release the $5.8 million judgment, which is in escrow, to Carroll by this coming Tuesday — or explain why he would not do so.
Carroll’s attorneys think Trump may be trying to buy time to mount another legal strategy, telling the judge that Trump’s request for an extension “appears to be little more than yet another play for time.”
“The case is separate from Trump’s appeal of a Manhattan civil jury’s 2024 award of $83.3m to Carroll for defamation,” The Guardian explains. “But her lawyers have suggested a legal scenario in which the president might seek to conjoin the cases and further delay payment of both.”
Carroll’s attorney Roberta Kaplan (no relation to the judge) wrote, “We can only assume that defendant is seeking … to buy time so he can try to concoct some new basis to put off paying plaintiff presumably in connection with his forthcoming petition and motion for a rehearing.”
Trump’s former attorney, Justin Smith, in one of his final acts, wrote to the Supreme Court suggesting that his client would be appealing the $83.3 million civil judgment.
Smith argued that the Supreme Court “may wish to consider the petitions together,” given they involve the same parties.
The larger judgment case involves possible questions of presidential immunity, and that has Carroll’s attorneys concerned.
“A conjoined case, Carroll’s lawyers fear, could result in both judgments being wiped out,” The Guardian reports.
The president has also made clear he is no fan of Judge Kaplan, after the jurist made several rulings that “angered” Trump.
“What else can you expect from a Trump Hating, Clinton appointed judge, who went out of his way to make sure that the result was as negative as it could possible be,” Trump wrote on Truth Social in 2023, “speaking to, and in control of, a jury from an anti-Trump area which is probably the worst place in the US for me to get a fair ‘trial’.”
Image via Reuters
Platner Scorched Over ‘Taking Time’ Video After New Accusation
Trump Sparks Fury Online After Posting Unblurred Video of Muslim Kindergartners in Hijabs
One Legal Maneuver Threatens to Undo Everything E. Jean Carroll Won
Inside the Group Helping MAGA Voters Walk Away — And What Finally Pushed Them
