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.
Trump warns Iran it ‘can’t blackmail’ US with Hormuz closure
Fox News reports on heightened tensions in the Middle East as Iran’s Revolutionary Guard reaffirms strict control over the Strait of Hormuz and fires on passing ships. President Donald Trump, speaking from the Oval Office, states the US naval blockade will remain in full force. White House correspondent Alex Hogan provides updates on the escalating diplomatic and military standoff.
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Hundreds of commercial tankers are stranded on both sides of the Strait of Hormuz after Iran shut the critical chokepoint on April 18, halting traffic and leaving crews trapped amid reports of gunfire and “traumatic experiences” on board.
The Strait of Hormuz is considered an international waterway under international law, through which ships have the right of transit passage, according to the United Nations Convention on the Law of the Sea (UNCLOS).
Roughly one-fifth of the world’s oil supply passes through the Strait of Hormuz, making it a critical chokepoint for global energy markets, according to the U.S. Energy Information Administration.
The U.K. Maritime Trade Operations (UKMTO) said Iranian gunboats opened fire on a tanker the same day, while a projectile struck a container vessel, damaging cargo.
STARMER AND MACRON ACCUSED OF ‘PLAYING AT BEING RELEVANT’ WITH STRAIT OF HORMUZ PLAN
U.S. Central Command said Tuesday that “U.S. Navy guided-missile destroyers are among the assets executing a blockade mission impacting Iranian ports.” (CENTCOM)
Audio released by maritime monitoring group TankerTrackers appears to capture the moment a vessel and its crew came under fire while approaching the strait, including a distress call from a crew member.
“Sepah Navy! Motor tanker Sanmar Herald! You gave me clearance to go… you are firing now. Let me turn back!” the crew member can be heard saying in the recording, according to TankerTrackers.
Iranian state media confirmed that shots were fired near vessels to force them to turn back, while the Ministry of External Affairs of the Government of India said the foreign secretary was deeply concerned.
Hapag-Lloyd, the world’s fifth-largest container shipping line, told Fox News Digital that it had activated a crisis team as its crews remain stuck on board vessels in the region.
“We have been working from Friday afternoon until today with the entire crisis team to bring the vessels out — in vain, unfortunately,” said Nils Haupt, senior director of group communications at Hapag-Lloyd AG.
“These events can easily lead to traumatic experiences. There is also a significant risk from sea mines, which has made insuring vessels for passage through the Strait nearly impossible.”
LISA DAFTARI: HORMUZ WHIPLASH PROVES TEHRAN CAN’T HONOR ANY DEAL IT SIGNS
“The crews are well, but they are becoming increasingly impatient and frustrated. It is very unfortunate that we could not leave today,” he added. “Many ships are still stuck in the Persian Gulf.”
“Our six ships are anchored near the port of Dubai, and all crews hope for an improvement in the situation,” Haupt said.
The Islamic Revolutionary Guard Corps (IRGC) said on April 18 that the strait would remain closed until the U.S. lifts its blockade on Iranian ports, warning ships not to move from anchorage or risk being treated as “enemy” collaborators.
Iran has previously argued that restrictions on its oil exports and shipping amount to “economic warfare,” framing actions in the Strait of Hormuz as a response to foreign pressure on its economy, according to statements from Iranian officials and state media in past incidents.
“Approaching the Strait of Hormuz will be considered cooperation with the enemy, and any violating vessel will be targeted,” the IRGC said in a statement carried by the semi-official Tasnim News Agency.
TRUMP ORDERS A BLOCKADE IN THE STRAIT OF HORMUZ AS TENSIONS WITH IRAN SOAR
Fishing boats dot the sea as cargo ships, in the background, sail through the Arabian Gulf toward the Strait of Hormuz off the United Arab Emirates, Friday, March 27, 2026. (AP Photo)
The United States imposed the blockade on Iranian ports to pressure Tehran to reopen the strait, with U.S. Central Command saying the measures are being enforced “impartially against all vessels.”
Hapag-Lloyd said its vessels have been stuck for weeks following the initial closure after the outbreak of war with Iran on Feb. 28.
“For us, it is critical that our vessels can pass through the strait soon,” Haupt said.
“We offer all crew members unlimited data so they can video call loved ones and access entertainment. Crews are strong, but after weeks on board there is growing monotony and frustration.”
“One crew experienced a fire on board from bomb fragments. Others have seen missiles or drones near their vessels,” he added.
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“They are resilient, but each additional day makes the situation more difficult, more monotonous, and more stressful.”
President Donald Trump said Iran had agreed not to close the strait again but after the closure, Trump called the situation “blackmail” and said the U.S. would not back down.
Shops and schools shut in northern Israel as residents protested a 10-day ceasefire with Lebanon that took effect on April 16, saying “nothing was achieved”. Israeli officials say operations may continue, with forces still deployed inside southern Lebanon.
Published On 19 Apr 2026
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.
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