World
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.
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.
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.
“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.
“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.
World
Pope Leo says remarks about world being ‘ravaged by a handful of tyrants’ were not aimed at Trump: report
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Pope Leo XIV said Saturday that remarks he made this week in which he said the “world is being ravaged by a handful of tyrants” were not directed at President Donald Trump, a report said.
The pope, speaking onboard a flight to Angola during his 10-day tour of Africa, said reporting about his comments “has not been accurate in all its aspects” and his speech “was prepared two weeks ago, well before the president ever commented on myself and on the message of peace that I am promoting,” according to Reuters.
The news outlet cited the pope as saying his comments were not aimed at Trump.
“As it happens, it was looked at as if I was trying to debate the president, which is not in my interest at all,” the pope reportedly said.
’60 MINUTES’ ACCUSED OF USING LEFT-LEANING CARDINALS TO BAIT TRUMP INTO FEUD WITH VATICAN
Pope Leo XIV answers journalists’ questions during his flight from Yaoundé, Cameroon, to Luanda, Angola, Saturday, April 18, 2026. (Luca Zennaro/Pool Photo via AP)
Vice President JD Vance later took to X to thank the pope for clearing the record.
“While the media narrative constantly gins up conflict — and yes, real disagreements have happened and will happen — the reality is often much more complicated,” Vance wrote. “Pope Leo preaches the gospel, as he should, and that will inevitably mean he offers his opinions on the moral issues of the day.
“The President — and the entire administration — work to apply those moral principles in a messy world,” he continued. “He will be in our prayers, and I hope that we’ll be in his.”
The vice president’s comments came days after he told Fox News’ Bret Baier on “Special Report” that it would be best for the Vatican to “stick to matters of morality.”
“Let the President of the United States stick to dictating American public policy,” Vance said Tuesday.
Trump last Sunday accused Pope Leo XIV of being “terrible” on foreign policy after the pontiff criticized the U.S.-Israeli war on Iran.
“He talks about ‘fear’ of the Trump Administration, but doesn’t mention the FEAR that the Catholic Church, and all other Christian Organizations, had during COVID when they were arresting priests, ministers, and everybody else, for holding Church Services, even when going outside, and being ten and even twenty feet apart,” Trump wrote in a Truth Social post.
“I don’t want a Pope who thinks it’s OK for Iran to have a Nuclear Weapon.”
POPE LEO SLAMS THOSE WHO ‘MANIPULATE RELIGION’ FOR MILITARY OR POLITICAL GAIN, TRUMP RESPONDS
Pope Leo XIV and President Donald Trump (Simone Risoluti/Vatican Media via Vatican Pool/Getty Images; Salwan Georges/Bloomberg via Getty Images)
During a speech in Cameroon on Thursday, the pope said, “We must make a decisive change of course — a true conversion — that will lead us in the opposite direction, onto a sustainable path rich in human fraternity.
“The world is being ravaged by a handful of tyrants, yet it is held together by a multitude of supportive brothers and sisters.
Pope Leo XIV speaks as he meets with the community of Bamenda at Saint Joseph’s Cathedral in Bamenda on the fourth day of an 11-day apostolic journey to Africa April 16, 2026. (Alberto Pizzoli/AFP via Getty Images)
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“Woe to those who manipulate religion and the very name of God for their own military, economic or political gain, dragging that which is sacred into darkness and filth.”
Fox News Digital has reached out to the White House for comment.
Fox News Digital’s Landon Mion contributed to this report.
World
Bulgaria votes in eighth election in five years
Bulgarians headed to the polls Sunday for the eighth time in five years, with anti-corruption candidate and former president Rumen Radev’s bloc tipped to win.
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The European Union’s poorest member has been through a spate of governments since 2021, when large anti-graft rallies brought an end to the conservative government of long-time leader Boyko Borissov.
Eurostat data shows Bulgaria consistently ranks last in the EU by GDP per capita. In 2025, Bulgaria (along with Greece) was at 68% of the EU average.
Radev, who has advocated for renewing ties with Russia and opposes military aid to Ukraine, was president for nine years in the Balkan nation of 6.5 million people.
He stepped down in January to lead newly formed centre-left grouping Progressive Bulgaria, with opinion polls before Sunday’s vote suggesting the bloc could gain 35% of the vote.
The former air force general has said he wants to rid the country of its “oligarchic governance model”, and backed anti-corruption protests in late 2025 that brought down the latest conservative-backed government.
“I’m voting for change,” Decho Kostadinov, 57, told reporters after casting his ballot at a polling station in the capital, Sofia, adding corrupt politicians “should leave — they should take whatever they’ve stolen and get out of Bulgaria”.
Polls are forecasting a surge in voter participation, with more than 3.3 million Bulgarians expected to cast ballots according to the Bulgarian News Agency.
Voting will close at 1700 GMT, with exit polls expected immediately afterwards. Preliminary results are expected on Monday.
‘Preserve what we have’
Borissov’s pro-European GERB party is likely to come second, according to opinion polls, with around 20%, ahead of the liberal PP-DB.
“I’m voting to preserve what we have. We are a democratic country, we live well,” said Elena, an accountant of about 60, who did not give her full name, after casting her vote in Sofia.
Front-runner Radev has slammed the EU’s green energy policy, which he considers naive “in a world without rules”.
He also opposes any Bulgarian efforts to send arms to help Ukraine fight back Russia’s 2022 invasion, though he has said he would not use his country’s veto to block Brussels’ decisions.
Pushing for renewed ties with Russia, Radev denounced a 10-year defence agreement between Bulgaria and Ukraine signed last month – drawing fresh accusations from opponents of being too soft on Moscow.
The ex-president also stoked outrage online for screening images at his final campaign rally of his meetings with world leaders including Russia’s Vladimir Putin.
“We need to close ranks,” he told around 10,000 cheering supporters at the rally, presenting his party as a non-corrupt “alternative to the perverse cartel of old-style parties”.
Borissov, who headed the country virtually uninterrupted for close to a decade, has dismissed suggestions that Radev brings something “new”.
At a rally of his party earlier this week, he insisted GERB had “fulfilled the dreams of the 1990s” with such achievements as the country joining the eurozone this year.
‘No one to vote for’
Radev is aiming for an absolute majority in the 240-seat parliament.
A lack of trust in politics has affected voter turnout, which slumped to 39% in the last election in 2024.
But with Radev rallying voters, high turnout is expected this time, according to analyst Boryana Dimitrova from the Alpha Research polling institute.
Miglena Boyadjieva, a taxi driver of about 55, said she always votes, but the “problem is that there is no one to vote for”.
“You vote for one person and get others. The system has to change,” she told reporters.
Political parties have called on Bulgarians to show up for the polls, also to curb the impact of vote buying.
In recent weeks, police have seized more than one million euros in raids against vote buying in stepped-up operations.
They have also detained hundreds of people, including local councillors and mayors.
World
How Cheap Drones Are Changing Wars Like the Ones in Ukraine and Iran
A 3-D rendering of an Iranian Shahed-136 drone, a device with two triangle-shaped wings attached to a central fuselage. It has an engine the size of a small motorcycle’s and carries 110 pounds of explosives.
Engine the size of a small motorcycle’s
Carries 110 pounds of explosives
One of the biggest takeaways of the war with Iran is that it has proven itself to be a surprisingly capable adversary against the United States. In addition to its willingness to go on the offensive, Iran has forced the U.S. and its regional allies to confront the rise of cheap drones on the battlefield.
Iranian drones, made with commercial-grade technology, cost roughly $35,000 to produce. That is a fraction of the cost of the high-tech military interceptors sometimes used to shoot them down.
Cheap drones changed the war in Ukraine, and they have enabled Iranians to exploit a gap in American defense investments, which have historically prioritized accurate but expensive solutions.
Countering drones has been a major priority for the Pentagon for years, according to Michael C. Horowitz, who was a Pentagon official in the Biden administration. “But there has not been the impetus to scale a solution,” he said.
In just the first six days, the U.S. spent $11.3 billion on the war with Iran. The White House and Pentagon have not provided updated estimates, but the American Enterprise Institute, a conservative-leaning think tank, estimated in early April that the U.S. had spent approximately between $25 and $35 billion on the war, with interceptors driving much of the cost. Many missile defense experts also fear interceptor stockpiles are now running dangerously low.
Here is a breakdown of some of the ways the U.S. and its allies have countered Iran’s drones, and why it can be so costly.
Air-based strikes
In an ideal scenario, an early warning aircraft spots a drone when it is still several hundred miles out from a target, and a fighter jet, like an F-16, is dispatched from a military base. The F-16 can then use Advanced Precision Kill Weapon System (APKWS) II rockets to shoot a drone from about six miles away.
A 3-D rendering of an F-16 fighter jet firing an APKWS II rocket from under one wing. Two to three rockets are fired per drone, as per air defense protocol. Two APKWS II rockets and an hour of F-16 flight cost approximately $65,000, a little less than twice that of the Iranian Shahed-136.
Two to three interceptors fired per drone
These types of defensive air patrols are cost-efficient, but haven’t always been available because of the vast scope of the conflict. Iran has also targeted early warning aircraft that the U.S. needs to detect a drone from that distance, according to NBC News.
The other option for detecting and shooting down drones is a variety of different ground-based detection systems, but these systems are all at a disadvantage, as their ability to spot low-flying drones is limited by the curvature of the earth.
Anti-drone defense systems
One ground-based defense system the U.S. and its allies have built specifically to counter drones at a shorter range is the Coyote. It can intercept drones up to around nine miles away.
A 3-D rendering of a Coyote Block 2 interceptor, which looks like a three-foot tube with small rockets at one end. Two Coyotes cost approximately $253,000 or about seven times that of the Iranian Shahed-136.
The Coyote is significantly cheaper than many of the other ground-based defense systems available to the U.S. and its allies and historically effective at defending important assets. But despite being both effective and cost-efficient, relatively few Coyotes have been procured by the U.S. military in recent years.
When Iran-backed militias launched attacks on U.S. ground troops in the region in 2023 and 2024, there were so few Coyotes available that troops had to shuffle the systems between eight different bases in the region almost daily, according to a report from the Center for a New American Security, a Washington think tank.
Ship-based anti-missile defenses
Many of the longer-range ground-based defense systems the U.S. and its allies can use to combat drones are more expensive, as they are designed to shoot down aircraft and ballistic missiles, not drones. A Navy destroyer’s built-in radar system, for instance, can detect drones from 30 miles away and shoot it down with Standard Missile 2 (SM-2) interceptors. As in the air-based strikes, military protocol stipulates that at least two missiles be fired.
A 3-D rendering of the deck of a Navy destroyer firing an SM-2 missile from a built-in launcher, which looks like a 15-foot missile launching from a grid of openings on the ship’s surface. Two SM-2 missiles cost approximately $4.2 million, about 120 times that of the Iranian Shahed-136.
This misalignment between America’s defense systems and current warfighting tactics started after the Cold War, when the anticipated threats were fewer, faster, higher-end projectiles, not mass drone raids.
Iran often launches multiple Shahed-136 drones at a time, given their low price tag. The drones are also programmed with a destination before launch and can travel roughly 1,500 miles, putting targets all across the Middle East within reach.
“This category of lower-cost precision strike just didn’t exist at the time that most American air defenses were developed,” said Mr. Horowitz.
Ground-based anti-missile defenses
The Army’s standard air-defense system is the Patriot. Typically stationed at a military base, it can shoot down a drone from up to around 27 miles away with PAC-3 Missile Segment Enhancement interceptors. Military protocol stipulates that at least two missiles be fired.
A 3-D rendering of a Patriot launcher loaded with 17-foot PAC-3 MSE missiles, which looks like a tilted shipping container with scaffolding. Two PAC-3 MSE missiles cost approximately $8 million, about 220 times that of the Iranian Shahed-136.
Patriot missile defense system
Air defense training teaches service members to prioritize using longer-range defense systems first to “get as many bites at the apple as you can,” but those are the most expensive, said Stacie Pettyjohn, a senior fellow and director of the defense program at the Center for a New American Security.
But a costly defense can still make economic sense to protect a valuable target, especially those that are difficult to repair or replace, such as the nearly $1.1 billion radar at a military base in Qatar and the $500 million air defense sensor at a base in Jordan that were damaged early in the conflict.
Ground-based guns
Finally, there is what one might call a last resort: a ground-based gun. When a drone is about a mile away or less than a minute from hitting its target, something like the Centurion C-RAM can begin rapidly firing to take down the drone.
A 3-D rendering of a Centurion C-RAM, which looks like a gun mounted to a rotating, cylindrical stand. The gun fires 75 rounds of ammunition per second. Five seconds of firing the gun costs $30,000, slightly less than a single Iranian Shahed-136.
Centurion Counter-Rocket, Artillery and Mortar
Fires 375 rounds of ammunition in 5 seconds
Even though it is fairly cost-effective, the Centurion C-RAM is not the best option because it has such a short range.
Interceptor drones
There’s also what one might call the future of fighting drones: A.I.-powered interceptor drones. Interceptor drones like the Merops Surveyor can theoretically hunt and take down enemy projectiles from a short range.
A 3-D rendering of a Surveyor drone, which looks like a three-foot tube with wings and a tail. The Merops drone costs approximately $30,000, a little less than a single Iranian Shahed-136.
Merops system: Surveyor drone
Eric Schmidt, the former Google chief executive, founded a company to develop the Merops counter-drone system in conjunction with Ukrainian fighters, who have already been combatting Iranian drones in the war with Russia for years.
The U.S. sent thousands of Merops units to the Middle East after the conflict began, but it is unclear whether they have been deployed. The military set up training on the system in the middle of the war, as reported by Business Insider.
Other attempts to lower the cost-per-shot ratio of taking out a drone have failed.
The Pentagon invested over a billion dollars in fiscal year 2024 researching directed energy weapons, or lasers, that would cost only $3 per shot and have a range of 12 miles. Those systems have yet to be used in the field.
Despite the cost imbalance, the real fear for many in the defense community is the depleted stockpile of munitions.
“What scares me is that we will run out of these things,” said Tom Karako, the director of the Missile Defense Project at the Center for Strategic and International Studies in Washington. “Not that we can’t afford them, but that we’ll run out before we can replace them.”
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