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FDA will drop two-study requirement for new drug approvals, aiming to speed access

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FDA will drop two-study requirement for new drug approvals, aiming to speed access

WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.

Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine piece published Wednesday.

The announcement is the latest example of Makary and his team changing longstanding FDA standards and procedures with the stated goal of slashing bureaucracy and accelerating the availability of new medicines.

Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments for new medications that serve “national interests.”

It contrasts with the FDA’s more restrictive approach to other products, including vaccines.

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In their piece published Wednesday, Makary and Prasad state that dropping the two-trial requirement reflects modern advances that have made drug research “increasingly precise and scientific.”

“In this setting, overreliance on two trials no longer makes sense,” they write. “In 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”

The FDA officials predicted the shift would lead to “a surge in drug development.”

Dr. Janet Woodcock, the FDA’s former drug director, said the change makes sense and reflects the FDA’s decades-long move toward relying on one trial, combined with supporting evidence, for various life-threatening diseases, including cancer.

“The scientific point is well taken that as we move toward greater understanding of biology and disease we don’t need to do two trials all the time,” said Woodcock, who led the FDA’s drug center for about 20 years before retiring in 2024.

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The two-study standard for drugs dates to the early 1960s, when Congress passed a law requiring the FDA to review data from “adequate and well-controlled investigations,” before clearing new medications. For decades, the agency interpreted that requirement as meaning at least two studies, preferably with a large number of patients and significant follow-up time.

The reason for requiring the second study was to confirm that the first trial’s results weren’t a fluke and could be reproduced.

But beginning in the 1990s, the FDA increasingly began accepting single studies for the approval of treatments for rare or fatal diseases that companies often struggle to test in large numbers of patients.

Over the last five years, roughly 60% of first-of-a-kind drugs approved each year have been cleared based on a single study. The shift reflects laws passed by Congress that directed regulators to be more flexible when reviewing drugs for serious or hard-to-treat conditions.

Woodcock said the new policy announced Wednesday will mainly impact drugs for common diseases that previously weren’t eligible for reduced testing standards.

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“It’s not the cancers and the rare diseases that will be affected by this,” she noted. “The agency has been approving those on a single trial already.”

The latest approach from FDA leadership contrasts with the agency’s recent actions on vaccines, gene therapies and other treatments.

Last week, the FDA’s vaccine division, headed by Prasad, refused to accept Moderna’s application for a new mRNA flu shot, saying its clinical trial was insufficient. Then on Wednesday the agency reversed course, saying it would review the vaccine after Moderna agreed to conduct an additional study in older people.

Separately, Prasad has rejected a string of experimental gene therapies and biotech drugs, citing the need for additional studies or more definitive evidence. The trend has weighed on the stocks of many biotech companies and clashed with Makary’s public statements promoting the speed and flexibility of the FDA’s reviews.

Woodcock said the drug industry will have to wait and see whether the FDA’s approach to promising experimental therapies changes.

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“Implementation will be everything,” she said. “Since the agency’s approach is unclear, and the industry is already baffled, I don’t think this adds any illumination.”

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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.

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As Hezbollah rejects truce, families on Israel’s northern border describe life under fire

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As Hezbollah rejects truce, families on Israel’s northern border describe life under fire

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Two days after another ceasefire was announced between Israel and U.S. terrorist designated group Hezbollah, Yulia Bar-Dan was standing outside her temporary home in Kibbutz Manara in northern Israel when the familiar sound of an interceptor echoed overhead. 

“There will probably be another siren soon,” she told Fox News Digital.

Minutes later, an alert appeared on her phone warning residents in northern Israel to take shelter.

For Bar-Dan, the scene captured the reality of life on Israel’s northern border nearly two years after Hezbollah joined the war against Israel on Oct. 8, 2023. 

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After Hezbollah entered the recent war in support of Iran, Washington launched a diplomatic effort aimed at turning the ceasefire into a broader arrangement for Lebanon. 

ISRAEL OPENS FIRE IN LEBANON AT ‘SUSPECTS’ ALLEGEDLY VIOLATING TRUCE, WHICH HAS ENTERED ITS SECOND DAY

Multiple rounds of talks between Israeli and Lebanese officials have taken place in Washington, and President Donald Trump has repeatedly announced ceasefire understandings aimed at restoring calm along the border. Residents of communities like Manara, Israel, say the rockets, drones and uncertainty never really stopped.

An Israeli soldier stands near military vehicles on the second day of the ceasefire between Israel and Hezbollah near the Israel-Lebanon border on Nov. 28. (Stoyan Nenov/Reuters)

“A ceasefire is supposed to be on both sides,” she said. “Not that Hezbollah keeps shooting at us and we just keep absorbing it.”

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When Fox News Digital first spoke to Bar-Dan in December 2024 during the war, she and her husband had fled Manara, Israel, with their three children and were living out of a single hotel room, unsure whether they would ever return home.

Today, roughly 200 of the kibbutz’s 280 residents have returned, Bar-Dan said. But many, including Bar-Dan’s family, still cannot live in their original homes because of war damage. 

Yulia Bar-Dan and her husband are pictured during quieter times at Kibbutz Manara, Israel.  (Yulia Bar-Dan)

Despite repeated ceasefire announcements, residents say normal life remains elusive.

“There hasn’t really been a routine or a quiet day since February,” she said.

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Schools officially reopened in early June, but Bar-Dan decided not to send her children.

“They take the bus to school,” she said. “What if there’s a siren on the way? I can’t take that chance.”

ISRAEL DESTROYS HEZBOLLAH’S ‘LARGEST PRECISION-GUIDED MISSILES MANUFACTURING SITE’ AS GROUP VOWS TO ‘FIGHT’

Hezbollah terrorists holding rifles are shown in this image.  (Fadel Itani/NurPhoto via Getty Images)

Her frustration is not directed at Hezbollah alone.

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Like many residents interviewed by Fox News Digital, Bar-Dan says there is a growing disconnect between the reality experienced on the border and the reality described by politicians.

“It doesn’t really matter where the decisions are being made,” she said. “The decisions just need to match reality. Right now there is a decision, but the reality is completely different.”

A year and a half after most of Manara’s residents were evacuated amid fears of a Hezbollah invasion, community leader Yochai Wolfin says residents have developed their own name for the current situation. 

“We call it ‘the ceasefire war,’” he said. 

The phrase has become common in the community.

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First came a year and a half of evacuation. Then came the return home. Then came what Wolfin describes as three months of “fire within a ceasefire.”

The uncertainty has become part of daily life.

Children study inside shelters. Parts of the kibbutz still lack protected rooms. Construction projects remain unfinished because contractors are reluctant to work so close to the border. 

He said many residents increasingly feel that the decisions determining their future are being made far from the communities that bear the consequences.

ISRAEL WARNS IT WILL GO AFTER LEBANON DIRECTLY IF CEASE-FIRE WITH HEZBOLLAH COLLAPSES

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A Lebanese man holds a Hezbollah flag near the border with Israel in the southern Lebanese village of Hula on Dec. 20, 2020. (Jalaa Marey/AFP)

“Who knows what tomorrow will bring?” Wolfin said. “We know who is calling the shots. We saw it a few days ago when Trump announced another ceasefire. But for us, the reality on the ground hasn’t changed.”

The comments come as Hezbollah Secretary-General Naim Qassem warned Thursday that northern Israel would remain unsafe as long as Israeli strikes continue in Lebanon, according to Reuters.

In a written statement broadcast on June 4, 2026, Qassem condemned the Washington-mediated framework as “absurd, humiliating, and insulting,” calling it a roadmap for surrender.

For residents of Israel’s northern border communities, the statements reinforced what many say they have been experiencing for months: a ceasefire that exists on paper but not in daily life.

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Naor Shamia, who heads Manara’s emergency response team, says residents increasingly worry that temporary emergency measures are becoming permanent.

“The fear isn’t today,” he said. “The fear is that this becomes years. We are in a deadlock.”

Across the border region, similar concerns are heard.

Fire burns at Kibbutz Manara following another attack. (Kibbutz Manara)

In the community of Adamit, resident Yael Cohen-Arazi described the contrast between the beauty surrounding her and the reality of living under constant threat.

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“Every morning I wake up and think I’m living in paradise,” she said in footage provided to Fox News Digital by the Israeli news agency TPS-IL. “Then there are the explosions that shake my soul.”

Her children, she said, have spent so much of their lives under fire that they no longer know what normal looks like.

“I tell them there are children who don’t live like this,” she said.

Back in Manara, Israel, another alert interrupted the afternoon.

Bar-Dan says she is not angry anymore. Mostly, she is tired and sad.

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“I feel bad for the soldiers,” she said. “Every day there is another casualty, and there is still no solution.”

Yet she insists she is staying.

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Members of the Kibbutz Manara rapid response unit respond to Hezbollah rocket attacks on Kibbutz Manara. (Kibbutz Manara)

“This is our home,” she said. “Someone has to live on the borders of this country.”

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Then another explosion sounded in the distance.

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Europe Today: Costa speaks exclusively to Euronews as EU-Western Balkans summit underway

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A high-stakes EU-Western Balkans summit is underway in Montenegro, with enlargement in the spotlight and France and Germany pushing for a more gradual path to EU integration. Our EU Editor Maria Tadeo is on the ground and speaks exclusively to European Council President António Costa.

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Taormina Film Festival Head Tiziana Rocca Says She Wants to Deliver a ‘Human Festival’ Amidst AI Boom, Asks Stars to Be ‘Generous’ to Local Audiences

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Taormina Film Festival Head Tiziana Rocca Says She Wants to Deliver a ‘Human Festival’ Amidst AI Boom, Asks Stars to Be ‘Generous’ to Local Audiences

Last year, Italian marketing guru Tiziana Rocca returned to the post of artistic director of Italy’s Taormina Film Festival eight years after she was forced to step down due to political infighting following a successful five-year stint. The festivals specialist, who nurtures close ties to Hollywood, revived Taormina’s competitive strands and brought major names such as Martin Scorsese to speak at the festival in her return year. 

This year’s edition is set to be another starry one, with major names such as Helen Mirren, Russell Crowe, Clive Owen, Jane Campion and Scott Eastwood set to land in the Sicilian town next week. Speaking with Variety amidst preparations for the upcoming event, Rocca says her priority is to build a festival that “feels like it is for everybody.”

“We have this incredible Greek theater with so much history that is a spectacular venue for 6,000 people,” she adds of the festival home, an imposing auditorium carved into a Sicilian hillside above the Ionian Sea. “But to fill this theater, we need to make sure that the program is very popular. This year, we have films from all over the world, and we want to have lots and lots of young people in the theater every evening. This festival energy is very important.”

Festival highlights this year include HBO’s “House of Dragon,” which will open the festival and the world premiere of Derrick Borte’s “Bear Country,” starring Crowe. The competitive strand will gather Berlin standouts such as Gore Verbinski’s “Good Luck, Have Fun, Don’t Die,” Ashley Walters’ “Animol” and Mahnaz Mohammadi’s “Roya,” as well as recent Cannes breakouts such as Rafiki Fariala’s “Congo Boy.”

“When the theater is full, and people are watching something together, it is a very emotional experience,” adds Rocca, who says one of her key missions with the festival is to keep ticket prices low so local families can attend screenings and events. “I respect the public, the city, and I know sometimes there is a lot of sacrifice involved in people coming to the festival. I want everybody to feel they have a chance to participate in the festival.”

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Having major Italian and international talent available to the public is another priority of Rocca’s, who states one of her “great joys” as an artistic director is being able to facilitate learning opportunities for budding filmmakers and young students. 

“I always try to get actors and directors to come, experience Taormina, and to be generous on the red carpet,” she continues. “I tell them: take the pictures, sign all the signs. Last year, we brought Martin Scorsese, who was supposed to give a 30-minute masterclass but spoke for an hour and a half with our students. He is so generous to the younger generations. He told them: ‘Don’t lose hope, follow your dreams.’” 

Rocca says budding filmmakers are living through “difficult times” when there is a “loss of hope” that one can make it in an industry that feels like it is always inching close to crisis. “Young people in film have lost a bit of hope. For this reason, I think it’s important for young students to hear from those who have made it and for them to hear that it was difficult for them at the start, too.” 

Tiziana Rocca and Michael Douglas at the Taormina Film Festival, courtesy of Taormina Film Festival

The artistic director is categorical in saying she wants Taormina to be “a human festival.” “I don’t like artificial intelligence. It cannot substitute anyone. All it can do is copy; it can’t create. For this reason, it’s very important to have a human factor to the festival, for it to be about people talking to each other. I try to avoid social media, I tell students to get off social media, to leave their phones in their pocket when they come to the festival.”

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Asked about opening this year’s festival with the Italian premiere of the first episode of HBO’s “House of the Dragon” Season 3, Rocca says it feels “natural” to screen series at the festival. “When HBO proposed that we screen the series, I felt we were the perfect place for it. Our beautiful theater is the perfect venue for all things spectacular, and ‘House of the Dragon’ is spectacular.” Stars set to attend the opening night gala at Taormina’s Greek amphitheater include Steve Toussaint (Lord Corlys Velaryon), Harry Collett (Jacaerys Velaryon), Bethany Antonia (Baela Targaryen) and Phoebe Campbell (Rhaena Targaryen).

As for the industry side of the affair, Rocca says it all boils down to Taormina as a meeting place. “I want the festival to be a place where people can meet, where they can talk about creativity,” she adds. “These encounters may lead to people working together. It has happened a lot in the past. We’re a festival everyone loves: the public, the industry, there’s a place for everyone. It’s an inclusive festival. For real people.”

Lastly, Rocca says the festival is key to the local economy of the Sicilian region: “The festival is very important for the industry but also for the region because it brings a lot of tourists. When we have the festival, everything is fully booked. No hotel room remains, restaurants are full, it is an event of true economic value.”

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