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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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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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Pete Hegseth warns narco-terrorists as U.S. backs Bolivia’s government amid coup warnings

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Pete Hegseth warns narco-terrorists as U.S. backs Bolivia’s government amid coup warnings

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War Secretary Pete Hegseth on Thursday said the United States remains committed to helping defend Bolivia’s fragile government amid ongoing warnings of a coup d’état.

In a post on X, Hegseth said the War Department and the Americas Counter Cartel Coalition (A3C), a recently established multinational military and political alliance, reject all attempts to overthrow the government of Rodrigo Paz Pereira a mere six months into his term.

“The United States is watching. Bolivia must not allow itself to fall prey to the old status quo of narco-terrorist dominance in the region,” Hegseth wrote. “We will continue to support our A3C partners like Bolivia to ensure that narco-terrorists are deterred from profiting on death and destruction in our hemisphere.”

PETE HEGSETH MAKES HOMELAND SECURITY TOP MISSION IN FIRST INTERVIEW AS SECRETARY OF WAR

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U.S. Secretary of Defense Pete Hegseth speaks at the IISS Shangri-La Dialogue security summit in Singapore on May 30, 2026. On Thursday, Hegseth reaffirmed the Trump administration’s support for Bolivia’s fragile government amid mass protests. (Edgar Su/Reuters)

Bolivia’s capital, La Paz, has been rocked by weeks of social unrest as mass protests have blocked streets in major cities amid economic inflation and rising fuel prices.

Bolivian Defense Minister Marcelo Salinas resigned Tuesday.

Upon taking office, Paz supported a land reform bill to boost agribusiness that Indigenous farmers said put them at risk of eviction. He further scrapped fuel subsidies, sending prices surging by nearly 90%. Motorists complained that the gasoline was contaminated and ruined their cars.

The Trump administration has said drug traffickers are responsible for inciting the mass unrest.

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RUBIO IDENTIFIES ‘SINGLE MOST SERIOUS THREAT’ TO THE US FROM WESTERN HEMISPHERE

Police officers fired tear gas at community members who seized the Humberto Suarez oil facility during protests calling for President Rodrigo Paz’s resignation in Santa Rosa del Sara, Bolivia, on June 3, 2026. The protests have caused fuel and food shortages. (Ipa Ibanez/Reuters)

“Let there be no mistake: the United States stands squarely in support of Bolivia’s legitimate constitutional government,” Secretary of State Marco Rubio wrote Wednesday on X. “We will not allow criminals and drug traffickers to overthrow democratically elected leaders in our hemisphere.”

“Let us not make any mistake about that; it is a coup financed by this perverse alliance between politics and organized crime across the region,” Deputy Secretary of State Christopher Landau said Tuesday, stating that the protests were part of an ongoing “coup d’état.”

Bolivia’s President Rodrigo Paz delivers a speech in La Paz on June 3, 2026, after naming Ernesto Justiniano as defense minister following the resignation of Marcelo Salinas amid protests. (Claudia Morales/Reuters)

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Meanwhile, former President Evo Morales, the country’s first Indigenous president who ruled for an unprecedented 14 years, is calling for early elections. “Paz only has two paths left: a suicidal decision like militarization or … an election in the next 90 days,” he wrote on X.

For almost two years now, Morales has been hiding out in Bolivia’s central coca-growing Chapare region, evading an arrest warrant on human trafficking charges relating to allegedly having sex with a 15-year-old girl. He rejects the allegations as politically motivated.

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