FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

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By MATTHEW PERRONE, Associated Press Health Writer

WASHINGTON (AP) — The Food and Drug Administration said Friday it will add a new warning and other limitations to a gene therapy for Duchenne’s muscular dystrophy that’s been linked to two patient deaths.

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The infused therapy from Sarepta Therapeutics will carry a boxed warning — the most serious type — alerting doctors and patients to the risk of potentially fatal liver failure with the treatment, the FDA said in a release.

The one-time therapy, Elevidys, has been under FDA scrutiny since the company reported the first of two deaths of teenage boys in March. Following a second death reported in June, the FDA briefly called for halting all shipments of the drug. But the agency quickly reversed course after facing pushback from patient families and libertarian activists close to President Donald Trump.

Elevidys is the first U.S.-approved gene therapy for Duchenne’s muscular dystrophy, a fatal muscle-wasting disease that affects boys and young men.

In addition to the boxed warning, the FDA is also limiting the drug’s approved use to patients who are 4 years old and up and can still walk. Previously the FDA had allowed the drug’s use in immobile patients, who generally have more advanced disease.

New labeling will also recommend weekly liver function monitoring for the first three months of treatment, as well as other precautionary steps.

Elevidys is Sarepta’s best-selling product and recent headwinds against the drug have weighed heavily on the company and its stock. In July, the Cambridge, Massachusetts-based company announced it would lay off 500 employees.

Sarepta Therapeutics Inc. shares rose 7.7% in trading after the FDA announcement, reflecting improved visibility for investors about the company’s outlook.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

US appeals court upholds hate crime convictions of 3 white men in 2020 killing of Ahmaud Arbery

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By RUSS BYNUM, Associated Press

SAVANNAH, Ga. (AP) — A federal appeals court on Friday upheld the hate crime convictions of three white men who chased Ahmaud Arbery through their Georgia subdivision with pickup trucks before one of them killed the running Black man with a shotgun.

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A three-judge panel of the 11th U.S. Circuit Court of Appeals took well over a year to rule after attorneys for the defendants urged the judges in March 2024 to overturn the case, arguing the men’s history of racist text messages and social media posts failed to prove they targeted Arbery because of his race.

Federal prosecutors used those posts and messages in 2022 to persuade a jury that Arbery’s killing was motivated by “pent-up racial anger.”

Even if the appeals judges had thrown out their hate-crime convictions, the trio faced no immediate reprieve from prison. That’s because they’re also serving life terms for murder after being convicted in a Georgia state court.

Father and son Greg and Travis McMichael armed themselves and used a pickup truck to pursue 25-year-old Arbery after spotting him running in their neighborhood just outside the port city of Brunswick on Feb. 23, 2020. A neighbor, William “Roddie” Bryan, joined the chase and recorded cellphone video of Travis McMichael shooting Arbery at close range.

More than two months passed without arrests, until Bryan’s graphic video of the killing leaked online. The Georgia Bureau of Investigation took over the case from local police as outrage over Arbery’s death became part of a national outcry over racial injustice. Charges soon followed.

All three men were convicted of murder by a state court in late 2021. After a second trial in U.S. District Court in early 2022, a jury found the trio guilty of hate crimes and attempted kidnapping.

Greg McMichael’s attorney, A.J. Balbo, declined to comment on the appellate ruling. Attorneys for Bryan and Travis McMichael did not immediately return phone and email messages.

US military’s 20th strike on alleged drug-running boat kills 4 in the Caribbean

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By BEN FINLEY, Associated Press

WASHINGTON (AP) — The U.S. military’s 20th strike on a boat accused of transporting drugs has killed four people in the Caribbean Sea, a Pentagon official said Friday, coming as the Trump administration escalates its campaign in South American waters.

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The latest strike happened Monday, according to the official, who wasn’t authorized to discuss the matter and spoke on condition of anonymity. It brings the death toll from the strikes that began in September to 80, with the Mexican Navy suspending its search for a survivor of a strike in late October after four days.

The attack, which occurred the same day that Defense Secretary Pete Hegseth announced two strikes had been carried out on Sunday, comes as the Trump administration expands the U.S. military’s already large presence in the region by bringing in the USS Gerald R. Ford aircraft carrier. The nation’s most advanced warship is expected to arrive in the coming days after traveling from the Mediterranean Sea.

Defense Secretary Pete Hegseth on Thursday formally named the mission Operation Southern Spear, emphasizing the growing significance and permanence of the military’s presence in the region. Once the Ford arrives, the mission will encompass nearly a dozen Navy ships as well about 12,000 sailors and Marines.

The Trump administration has insisted that the buildup of warships is focused on stopping the flow of drugs into the U.S., but it has released no evidence to support its assertions that those killed in the boats were “narcoterrorists.” The strikes have targeted vessels largely in the Caribbean Sea but also have taken place in the eastern Pacific Ocean, where much of the cocaine from the world’s largest producers is smuggled.

The USS Gravely destroyer arrives to dock for military exercises in Port-of-Spain, Trinidad and Tobago, Sunday, Oct. 26, 2025. (AP Photo/Robert Taylor)

Some observers say the aircraft carrier is a big new tool of intimidation against Venezuelan President Nicolás Maduro, who faces charges of narcoterrorism in the U.S. Experts disagree on whether American warplanes may bomb land targets to pressure Maduro to step down.

Secretary of State Marco Rubio says the U.S. doesn’t recognize Maduro, who was widely accused of stealing last year’s election, as the leader of Venezuela and has called the government a “transshipment organization” that openly cooperates with those trafficking drugs toward the U.S.

Maduro has said the U.S. government is “fabricating” a war against him. Venezuela’s government this week touted a “massive” mobilization of troops and civilians to defend against possible U.S. attacks.

Trump has justified the attacks by saying the United States is in “armed conflict” with drug cartels and claiming the boats are operated by foreign terror organizations that are flooding America’s cities with drugs.

Lawmakers, including Republicans, have pressed for more information on who is being targeted and the legal justification for the strikes.

Rubio and Hegseth met with a bipartisan group of lawmakers who oversee national security issues last week, providing one of the first high-level glimpses into the legal rationale and strategy behind the strikes.

Senate Republicans voted a day later to reject legislation that would have put a check on Trump’s ability to launch an attack against Venezuela without congressional authorization.

Wild say Marco Rossi’s lower body injury is ‘week to week’

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After recovering from a rough start with a 4-1-1 record so far in November, the Minnesota Wild are looking to keep that positive momentum. But they will have to do so, at least for a time, without their top-line center.

Wild coach John Hynes confirmed on Friday that Marco Rossi is out for the foreseeable future, labeling the Austrian’s lower body injury as week-to-week.

“Something that was bothering him a little bit and started to get a little bit worse,” Hynes said. “Now he’s out.”

Rossi, 24, blocked a shot early in the Wild’s 2-1 overtime loss in Philadelphia on Oct. 18. He continued playing, despite appearing to be in some pain, and assisted on Minnesota’s lone goal. But he was scratched from the lineup two nights later for a win versus the Rangers in New York.

Since then, Rossi had been in the lineup for the past 11 games but apparently has not fully recovered from the injury suffered in Philadelphia.

Despite being of average size, and playing a net-front game where injuries are more common, Rossi has been one of Minnesota’s more durable players. The game he missed in October was his first night off the ice in two years. In 17 games this season, Rossi has four goals and nine assists. But even Hynes acknowledged that in the modern NHL, just because you are in the lineup does not mean you are fully healthy.

“Just the nature of the league, some guys can get through and play through,” Hynes said. “Now, you don’t play 82 games if you don’t play banged up. … To play every game of a season, at this level, you’re not playing 100 percent for most of them. But he was able to get through last year.”

Rossi signed a three-year, $15 million contract extension late in the summer after considerable talk in the off-season that he could be traded for the right return.

His current absence leaves the Wild thin in the experienced centers department, especially with veteran Nico Sturm still recovering from a training camp injury and not expected to be available until December.

In the near-term, rookie Danila Yurov — who has been in and out of the lineup as he adjusts to the style and pace of the NHL — was elevated to center the team’s third line, and Ben Jones will center the fourth line. Jones has played six games without recording a point but has been solid in the faceoff circle.

During the team’s Friday morning practice at TRIA Rink, Hynes put Ryan Hartman at center on the top line between Kirill Kaprizov and Mats Zuccarello. He had Yurov centering the third line between Vinnie Hinostroza and Vladimir Tarasenko, and the fourth line was Jones between Marcus Foligno and Yakov Trenin.

The second line of Matt Boldy, Joel Eriksson Ek and Marcus Johansson remained intact.

“Marco has a lot of roles on the team that now we’re going to have to fill,” Hynes said. “So, we’ll see if we can give Danila what he can handle but continue to inch him along and progress him as long as he continues to progress.”

Yurov, who signed in May after spending parts of the previous five seasons in the Russian KHL, has two goals and no assists in his first 13 NHL games.

The loss of Rossi, at least for the time being, could also prompt Wild general manager Bill Guerin to more actively pursue an addition to the roster from the outside. With the Wild off to a slow start, and with salary cap money at his disposal, Guerin has said publicly and recently that he is open to exploring the trade market.

The Wild host Anaheim on Saturday and Vegas on Sunday. Both games start at 5 p.m. at Grand Casino Arena.

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