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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.
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.
The 2026 World Cup final is set. A match between the reigning world champions versus the reigning European champions. Between the sport’s greatest player in history, Lionel Messi, versus its ascendant teenage prodigy, Lamine Yamal. It will be Argentina versus Spain, Sunday in East Rutherford, N.J.
The irrepressible Albiceleste overcame a 1-0 deficit against England in Wednesday’s semifinal, equalizing in the 85th minute and knocking in a go-ahead goal in extra time to send Argentina to its second consecutive World Cup final. Spain, meanwhile, is seeking to add a second star to its national jersey and first since 2010.
At stake in global soccer’s greatest match is more than just sporting history, however. Below, four takeaways for the business of soccer based on the Argentina-Spain matchup.
A battle of the high rollers
Lionel Messi, at 39, remains soccer’s best-paid endorser, raking in $70 million in off-pitch earnings for the current season, according to Sportico estimates. With his annual contract at Inter Miami earning him an additional $70 million, he is the sport’s second-highest paid player in the entire World Cup field behind only Cristiano Ronaldo. Overall, Messi is the fifth-highest paid athlete of all time, with $1.99 billion in career earnings.
But Lamine Yamal, the 19-year-old wunderkind from Spain, is no slouch: He’s earned $33 million this past year from Barcelona, and an additional $10 million from sponsors like Adidas and American Eagle. Currently ranked No. 10 among Sportico’s highest paid World Cup footballers, Yamal could leapfrog a few places higher by the next World Cup, particularly if he burnishes his already impressive resumé with a strong showing and a Spain victory on Sunday.
A knockout victory for Adidas
Sunday’s final will be an all-Adidas affair, with the company outfitting both Spain and Argentina and pitting two of its marquee stars against one another.
The last Adidas vs. Adidas World Cup final was Germany against Argentina in 2014. That year, Adidas saw currency-neutral sales of soccer products rise by 20% to $2.4 billion (€2.1 billion).
An Adidas spokeswoman declined to specify sales projections for the 2026 World Cup but said in a statement that the company is “proud” to outfit both finalists at this year’s tournament.
Archrival Nike made a splashy entrance into this year’s World Cup, with a star-studded commercial honoring stars like Kylian Mbappé and Erling Haaland, the latter of whom became a breakout hit in the U.S. But instead of the World Cup trophy, Nike walks away from the 2026 tournament with the rights to Germany’s national team.
FIFA’s ticket pricing
As of Wednesday evening, get-in prices for Sunday’s final started at $8,900 in the nosebleeds, per Ticketmaster, while lower-bowl seats ran as high as $24,000.
But unlike the lead-up to the tournament’s group stage matches, where the sticker shock for four-figure ticket prices led to large blocks of seats going unsold until the last minute, only a handful of seats to Sunday’s final were available for resale on Ticketmaster.
The result is a reflection of FIFA’s ticket pricing strategy for the North American-hosted World Cup: set prices eye-poppingly high from the jump and limit the flow of cash into reseller’s hands.
Soccer’s Hottest Clubs: La Liga and MLS
A Spain and Argentina final reflects well on Spain’s LaLiga after the professional men’s league failed to put a representative in the Champions League final for a second year in a row. A whopping 17 players on La Roja’s roster come from the domestic top-flight league– of whom eight play for Barcelona, while the lion’s share of players for Argentina (7) also play within LaLiga.
And while MLS can’t compete on quantity of players taking the pitch on Sunday, the ability to market around Inter Miami star Messi into and through the final match is the dream scenario for the U.S. league. This week, MLS launched a new campaign aimed at converting World Cup fans to year-round club supporters, anchored by Messi and ubiquitous pitchman and England legend David Beckham. Some 22 of the league’s 30 clubs are offering complimentary single-game tickets to first-time MLS match attendees.
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President Donald Trump said he believes Russian President Vladimir Putin is ready to reach an agreement to end the war in Ukraine, even as Moscow warned Wednesday that Western troops deployed to enforce any eventual peace deal would become Russian military targets.
“I say, ‘Vladimir, it’s time for you to stop. It’s time for this war to end,’” Trump told Fox News chief foreign correspondent Trey Yingst in an interview released Tuesday.
Trump said he believed Putin was “ready to make a deal” to end the fighting.
ANOTHER NATO ALLY SIGNS ONTO EUROPEAN NUCLEAR UMBRELLA AS CONTINENT BOOSTS SELF-DEFENSE
Meanwhile, fighting continued across Ukraine and Russian-occupied territory.
The intensifying drone war has forced both militaries to search for additional ways to intercept unmanned aircraft, sometimes using weapons designed decades before modern drones emerged.
A video supplied by East2West shows a Russian soldier apparently losing control of a Soviet-era YakB-12.7 rotary machine gun mounted on an improvised ground platform.
Russian President Vladimir Putin and President Donald Trump meet in 2019, before their relationship began to sour. (Brendan Smialowski/AFP via Getty Images)
The weapon begins spinning violently, dragging the service member around before throwing him several yards from the mounting. Another soldier ducks as the gun swings in his direction.
East2West reported that no one was injured, though Fox News Digital has not independently verified the location, date or circumstances of the footage.
The four-barrel machine gun was originally developed for use aboard the Soviet-designed Mi-24 Hind attack helicopter. Russian forces have reportedly attempted to repurpose such weapons as ground-based defenses against Ukrainian drones, East2West news reported.
TRUMP SAYS US WILL LET UKRAINE MAKE PATRIOT MISSILES IN MAJOR POLICY SHIFT
An explosion lights up the sky over the city during a Russian missile and drone strike amid Russia’s attack on Ukraine in Kyiv July 2, 2026. (Gleb Garanich/Reuters)
On Wednesday, Russian Foreign Ministry spokeswoman Maria Zakharova said any multinational force deployed by Ukraine’s allies after a ceasefire would be unacceptable to Moscow.
“We would regard such units as legitimate military targets,” Zakharova said, according to a Reuters report published Wednesday.
Members of the Western “coalition of the willing” reaffirmed at a meeting in Paris this week that they intend to deploy a multinational force after hostilities end. The proposed force would seek to reassure Ukraine and help Kyiv rebuild its military.
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Ukraine’s military said Wednesday that its forces struck the Balaklava thermal power station in Russian-occupied Crimea, a facility that accounts for nearly half of the peninsula’s electricity generation, according to Reuters.
Russia, meanwhile, launched another major drone and missile attack against Ukraine’s southern Odesa region, killing three people, regional Governor Oleh Kiper said. He said civilian, industrial and port infrastructure had been targeted during five consecutive days of Russian attacks.
Emergency services personnel work to extinguish a vehicle fire after a Russian drone attack in the Kyiv region, Ukraine, May 5, 2026. (Ukrainian Emergency Service/AP)
Ukrainian President Volodymyr Zelenskyy also said Wednesday that Ukraine expects to develop the technical capability to manufacture missiles for U.S.-made Patriot air-defense systems by the end of 2026.
Reuters contributed to this story.
Monitor ranks Toronto as having the worst air quality on earth, surpassing Kinshasa, DR Congo, and New Delhi, India.
Published On 16 Jul 2026
Toronto’s air quality has ranked the worst among all major cities in the world as smoke from wildfires in northwestern Ontario blankets the skies and spreads into the northeastern United States, triggering multiple health warnings and evacuations.
Wildfires continued burning through sparsely populated areas hundreds of miles from Toronto, Canada’s largest city, on Wednesday, sending smoke over a wide area, although cities in the area are not being threatened.
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Environment Canada reported an Air Quality Health Index reading of 10+, classified as “very high risk”, for Toronto. Forecasts suggested that hazardous conditions could persist through Thursday night.
IQAir, a Swiss air quality technology company, ranked Toronto as having the worst air quality across the globe, surpassing the Democratic Republic of the Congo’s Kinshasa and India’s New Delhi.
“The biggest contributor to Toronto’s spike in air pollution right now is wildfires, though the higher-than-average temperatures are also playing a role,” Armen Araradian of IQAir told the AFP news agency.
While this year’s wildfire season in Canada has been fairly muted compared with recent years, there are more than 800 active fires nationwide.
A video that went viral on social media showed a Canadian National train surrounded by fire near Armstrong, Ontario. Canadian National employees in the area and residents of Armstrong were evacuated on Monday night, the railroad operator said in a statement. It suspended rail operations near Armstrong as a precaution.
Smoke from the wildfires also worsened air quality across the border in the US, with the states of Pennsylvania, New York, Connecticut, Massachusetts, Maine and New Hampshire particularly affected.
Authorities in New York City have issued an alert over unhealthy air quality, urging residents to reduce strenuous outdoor activity and take extra breaks if they are outside on Wednesday and Thursday.
The National Weather Service said smoke could linger until the end of the week.
“We probably haven’t seen the worst of it yet for New York City. We probably haven’t seen the worst of it yet for the Great Lakes and upstate, and New England yet either,” Dan Westervelt, Lamont associate research professor at Columbia University, told the Reuters news agency.
More than 80,000 people are expected to attend the FIFA World Cup final at an open-air stadium in New Jersey on Sunday, with another 50,000 planning to watch the game from New York City’s Central Park, where skies appeared hazy.
New York Governor Kathy Hochul urged people, especially those with health conditions, to exercise caution.
The Canadian government has said that wildfire season began more slowly this year than in 2023 or 2025 – the two worst seasons for wildfires – but warned that fires were likely, due to warmer-than-usual temperatures across the country.
It said some 835 active fires were burning across the country on Wednesday, with 112 considered out of control, and most in the central provinces of Manitoba, Saskatchewan and Ontario.
They have burned 1.9 million hectares (4.7 million acres) so far.
Greg Evans, a professor of chemical engineering and applied chemistry at the University of Toronto, said the city had been simultaneously hit with severe heat and wildfire smoke.
“I expect that this will occur more frequently over the coming decades, so cities and residents need to prepare for this in the future,” he said.
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