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The Dictatorship

FDA drug approvals: Makary and Prasad say one study will be enough

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FDA drug approvals: Makary and Prasad say one study will be enough

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 Macary and a top deputy, Dr. Vinay Prasadwrote 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 coursesaying 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.

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The Dictatorship

Peace talks fail after U.S. warships launch risky Strait of Hormuz action

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High-stakes peace negotiations between the United States and Iran resulted in failure to end the war early Sunday morning local time in Islamabad after U.S. military warships crossed the Strait of Hormuz in a risky effort to open the waterway.

Vice President JD Vance, who led the U.S. delegation, announced that American negotiators were leaving Pakistan after giving the Iranians their “final and best offer,” which suggested his team had given Tehran a deadline.

“We’ll see if the Iranians accept it,” the vice president said during a brief news conference. U.S. delegates, he said, “could not get to a situation where the Iranians were willing to accept our terms.”

The failure of the face-to-face talks after 21 hours presented President Donald Trump with a stark choice: He can continue negotiations and play for time as part of an effort to stabilize soaring U.S. energy prices and plummeting markets, or he can wage new air strikes to try to reopen the strait by force.

As the two sides met in a marathon session, the U.S. military announced two of its warships had transited the strait and operated in the Persian Gulf as part of a broader operation to clear the vital trade corridor of sea mines that were laid by Iran’s Islamic Revolutionary Guards Corps.

Iranian forces have threatened to fire on ships that try to transit the strait without their permission. There were no immediate reports of Iranian forces firing on the two U.S. Navy destroyers.

Mark Hertling, a former U.S. Army general and MS NOW contributor, said it appeared the Trump administration was “testing Iran” to see whether its forces would dare fire on U.S. ships during peace talks.

Gregory Brew, a senior Iran and energy analyst with the Eurasia Group, a geopolitical risk consulting firm, said the U.S. military move was dangerous but he predicted, “I don’t think the Iranians will fire on them.”

Vance led the highest-level face-to-face meeting between the two warring adversaries since 1979. Parliamentary Speaker Mohammad Bagher Ghalibaf initially said his country would not negotiate unless two key measures — a ceasefire in Lebanon and the release of Iran’s heavily sanctioned assets — were met first.

Sal Mercogliano, a professor at the U.S. Merchant Marine Academy and Campbell University, said the U.S. demining operation was a key step in restoring confidence among oil tanker owners that they can move through the strait safely.

“It is also an effort to alleviate the security concerns of the crews, ships and owners stuck in the Persian Gulf,” said Mercogliano, who criticized the administration for failing to send enough U.S. ships to protect the strait.

The Islamic Republic regime is seeking to retain full sovereignty over the strait — it’s greatest strategic advantage — and has plans to charge oil tankers with hefty fees for safe passage.

A foreign diplomat inside Tehran who is close to the talks being held in Islamabad told MS NOW that Iranians felt as though they had the upper hand.

Experts agreed. Nicole Grajewski, an assistant professorat Sciences Po in Paris and an associate at the Harvard Kennedy School’s Belfer Center, told MS NOW that the Iranian delegation is pleased Vance is leading the talks because they see him as opposing U.S. wars in the Middle East.

“Iran isn’t expecting much but are pleased about Vance,” Grajewski told MS NOW. She said the Iranian delegation is under pressure to secure an agreement regarding Israel’s attacks on Lebanon and she noted that Ghalibaf, a former commander of Iran’s missile forces, is unlikely to agree to reduce Iran’s missile arsenal, a priority for the U.S. and Israel.

Trump said Friday that the U.S. military was readying warships to strike Iran if the negotiations failed.

Iranian officials have demanded that ships each pay a toll of up to $2 millionto pass safely through the strait, which could generate up to $100 billion a year. The revenue would benefit the Islamic Revolutionary Guard Corps, which operates Iran’s ballistic missile arsenal.

Hundreds of ships trying to pass through the strait remain stranded. After announcing the two-week ceasefire, Trump indicated the U.S. would be willing to ease primary and secondary sanctions on Iran. He had previously floated the idea of joining Iran in collecting tolls from vessels in the strait, but later walked those comments back, telling reporters “we’re not gonna let that happen.”

Israeli Prime Minister Benjamin Netanyahu said he instructed the Israeli Cabinet to begin direct negotiations with Lebanon in Washington next week after Trump instructed him to scale back the assault on Lebanon amid U.S.-Iranian negotiations and a temporary cease-fire agreement reached on Tuesday. The deal was struck after Trump threatened to end Iranian civilizationstirring MAGA revolt.

But heavy Israeli strikes have continued in Lebanon. Israel struck more than 200 Hezbollah targets across Lebanon overnight, according to The Associated Press. Pakistani Prime Minister Shehbaz Sharif asked all warring countries to adhere to the ceasefire amid Israel’s continued bombardment of Lebanon and reports earlier this week of Iranian attacks on countries including Qatar, the UAE and Kuwait.

Vance is joined in Islamabad by special envoy Steve Witkoff and Jared Kushner, the president’s son-in-law, along with Andrew Baker, Trump’s deputy national security advisor, and Michael Vance, the vice president’s national security advisor. Ghalibaf is joined by Iranian Foreign Minister Abbas Araghchi.

Julia Jester and Emily Hung contributed to this report.

Sydney Carruth is a breaking news reporter covering national politics and policy for MS NOW. You can send her tips from a non-work device on Signal at SydneyCarruth.46 or follow her work on X and Bluesky.

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David Rohde

David Rohde is the senior national security reporter for MS NOW. Previously he was the senior executive editor for national security and law for NBC News.

Jake Traylor is a White House correspondent for MS NOW.

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The Dictatorship

U.S. Vice President JD Vance says talks with Iran ended after 21 hours without reaching agreement

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U.S. Vice President JD Vance says talks with Iran ended after 21 hours without reaching agreement

ISLAMABAD (AP) — U.S. Vice President JD Vance said negotiations ended early Sunday between the United States and Iran without a peace deal after the Iranians refused to accept American terms to not develop a nuclear weapon.

The high-stakes talks ended after 21 hours, Vance said, with the vice president in constant communication with U.S. President Donald Trump and others in the administration.

“But the simple fact is that we need to see an affirmative commitment that they will not seek a nuclear weapon, and they will not seek the tools that would enable them to quickly achieve a nuclear weapon,” Vance told reporters. “That is the core goal of the president of the United States. And that’s what we’ve tried to achieve through these negotiations.”

The vice president said he spoke with Trump “a half dozen times, a dozen times, over the past 21 hours” and also spoke with Secretary of State Marco Rubio, Treasury Secretary Scott Bessent and Adm. Brad Cooper, head of the United States Central Command.

“We were constantly in communication with the team because we were negotiating in good faith,” Vance said, speaking at a podium in front of a pair of American flags with special envoy Steve Witkoff and Jared Kushner to his side. “And we leave here, and we leave here with a very simple proposal, a method of understanding that is our final and best offer. We’ll see if the Iranians accept it.”

Trump had said he would suspend attacks against Iran for two weeks. Vance’s comments did not indicate what will happen after that time period expires or if the ceasefire will remain in place.

War enters seventh week

The historic talks ended days after a fragile, two-week ceasefire was announced, as the warthat has killed thousands of people and shaken global markets entered its seventh week. Two Pakistani officials said discussions between the heads of the delegations will resume after a break.

Some technical personnel from both teams are still meeting, said the officials, who spoke on condition of anonymity because they were not authorized to brief the press.

Meanwhile, the U.S. military said two destroyers transited the Iran-gripped Strait of Hormuzahead of mine-clearing work, a first since the war began. Iran’s state media, however, said the joint military command denied that.

“We’re sweeping the strait. Whether we make a deal or not makes no difference to me,” Trump told journalists as talks continued and the time approached 2 a.m. in Islamabad. He called negotiations “very deep.” Iranian state TV noted what it called “serious” differences.

The U.S. delegation led by Vanceand the Iranian one led by Parliament Speaker Mohammad Bagher Qalibafdiscussed with Pakistan how to advance the ceasefire already threatened by deep disagreements and Israel’s continued attacks against the Iranian-backed Hezbollah in Lebanonwhose health ministry said the death toll has surpassed 2,000.

Since the Islamic Revolution in Iran in 1979, the most direct U.S. contact had been in 2013 when President Barack Obama called newly elected President Hassan Rouhani to discuss Iran’s nuclear program. Obama’s secretary of state, John Kerry, and counterpart Mohammad Javad Zarif later met during negotiations toward the 2015 Iran nuclear deal — a process that lasted well over a year.

Now the far broader talks feature Vance, a reluctant to defendof the war who has little diplomatic experience and warned Iran not to “try and play us,” and Qalibaf, a former commander with Iran’s powerful Revolutionary Guard who has issued some of Iran’s most fiery statements since fighting began.

Iran sets ‘red lines’ including compensation for strikes

Iran’s state-run news agency said the three-party talks began after Iranian preconditions, including a reduction in Israeli strikes on southern Lebanon, were met.

Iran’s delegation told state television it had presented “red lines” in meetings with Pakistani Prime Minister Shehbaz Sharif, including compensation for damage caused by U.S.-Israeli strikes that launched the war on Feb. 28 and releasing Iran’s frozen assets.

The war has killed at least 3,000 people in Iran, 2,020 in Lebanon, 23 in Israel and more than a dozen in Gulf Arab states, and caused lasting damage to infrastructure in half a dozen Middle Eastern countries. Iran’s grip on the Strait of Hormuz has largely cut off the Persian Gulf and its oil and gas exports from the global economy, sending energy prices soaring.

Reflecting the high stakes, officials from the region said Chinese, Egyptian, Saudi and Qatari officials were in Islamabad to indirectly facilitate talks. The officials spoke on condition of anonymity to discuss the sensitive matter.

In Tehran, residents told The Associated Press they were skeptical yet hopeful after weeks of airstrikes left destruction across their country of some 93 million people.

“Peace alone is not enough for our country because we’ve been hit very hard, there have been huge costs,” 62-year-old Amir Razzai Far said.

In his strongest words yet, Pope Leo XIV denouncedthe “delusion of omnipotence” fueling the war.

US sending forces to help mine-clearing on the strait

Iran’s closure of the Strait of Hormuz has proved its biggest strategic advantage in the war. Around a fifth of the world’s traded oil had typically passed through on over 100 ships a day. Only 12 have been recorded transiting since the ceasefire.

On Saturday, Trump said on social media that the U.S. had begun “clearing out” the strait.

“Today, we began the process of establishing a new passage and we will share this safe pathway with the maritime industry soon,” U.S. Central Command commander Adm. Brad Cooper later said. The U.S. statement about the destroyers added: “Additional U.S. forces, including underwater drones, will join the clearance effort in the coming days.”

Iranian Foreign Minister Abbas Araghchi had said Tehran was entering negotiations with “deep distrust” after  strikeson Iran during previous talks. Araghchi, part of Iran’s delegation in Pakistan, said Saturday that his country was prepared to retaliate if attacked again.

Iran’s 10-point proposal ahead of the talks called for a guaranteed end to the war and sought control over the Strait of Hormuz. It included ending fighting against Iran’s “regional allies,” explicitly calling for a halt to Israeli strikes on Hezbollah.

The United States’ 15-point proposal includes restricting Iran’s nuclear program and reopening the strait.

Israel and Lebanon will have direct negotiations

Israel pressed ahead with strikes in Lebanon after saying there is no ceasefire there. Iran and Pakistan have disagreed.

Negotiations between Israel and Lebanon are expected to begin Tuesday in Washington, Lebanese President Joseph Aoun’s office has said, after Israel’s surprise announcement authorizing talksdespite the countries lack of official relations.

But as thousands in Lebanon protested the planned negotiations on Saturday, Prime Minister Nawaf Salam said he had postponed a planned trip to Washington “in light of the current internal circumstances.” His absence should not affect talks as the first round is expected to be at the ambassadorial level.

Israel wants Lebanon’s government to assume responsibility for disarming Hezbollah, much like was envisaged in a November 2024 ceasefire. But the militant group has survived efforts to curb its strength for decades.

Hezbollah joined the war in support of Iran in the opening days. Israel followed with airstrikes and a ground invasion.

The day the Iran ceasefire deal was announced, Israel pounded Beirut with airstrikeskilling more than 300 people in the deadliest day in Lebanon since the war began, according to the country’s Health Ministry.

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The Dictatorship

The Trump family’s conflicts of interest are of no interest to Fox News

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ByMatt Gertz

Fox News programs that fixated on the international business interests of Hunter Bidenformer President Joe Biden’s son, are utterly uninterested in the voluminous conflicts of interest between President Donald Trump and his family members and the Persian Gulf states affected by his strategically disastrous war of choice against Iran.

The president, his eldest sons, Don Jr. and Eric, and his son-in-law, Jared Kushner, are enmeshed in a sprawling set of business deals in Saudi Arabia, the United Arab Emirates, Oman and Qatar. Those deals often involve members of the royal families of those states or the entities they control.

But since just before the beginning of the year, as Trump’s saber-rattling led to U.S. military deployments and became the war launched by American and Israeli forces on Feb. 28, through April 8, Fox’s evening programs that air from 5 p.m. to midnight ET have referenced such Trump family conflicts of interest only twice — both of which were passing mentions, and neither of which came during a discussion of the Iran conflict — according to a Media Matters review of the Nexis transcript database.

No substantive evidence ever emerged that Joe Biden profited from Hunter Biden’s foreign business dealings.

Many of the network’s highest-rated hosts carried out a yearslong obsession with what Fox host Sean Hannity described as the “Biden Crime Family,” mentioning Biden’s son at least 13,440 times over a period of less than 16 months of Biden’s presidency.  Their feverish conspiracy theory postulated that Hunter Biden had served as a “bag man” for his father, soaking up money funneled from foreign entities and kicking a share back to Joe Biden, who would then use his elected office to help his son’s business partners.

No substantive evidence ever emerged that Joe Biden profited from Hunter Biden’s foreign business dealings. The dealings in question largely occurred when Joe Biden was a private citizen, and the primary instance the conspiracy theorists have cited as evidence of him taking state action on behalf of one of his son’s clients — that he, as vice president, pushed for the removal of Ukraine’s top prosecutor in order to benefit one of his son’s clients — was manifestly bogus.

But Trump and his family members appear to have adopted influence-dealing on a dramatically larger scale than the Biden family was ever accused of. And the Trumps’ sprawling set of business deals with Gulf state royals and the sovereign wealth funds they control cannot be disentangled from the president’s decision-making in launching and continuing a war of choice against Iran.

Saudi Arabia and the UAE reportedly urged Trump to launch the war against Iran, and both states reportedly pressed the U.S. to protect them by escalating the conflict “until Iran is decisively defeated.” Qatar, meanwhile, traditionally serves as the regional intermediary between the Iranian regime and Western governments, and has pushed for negotiations.

Those states aren’t just U.S. allies whose views must be weighed by American leaders — their leaders have spent the past few years enriching the president’s family.

In perhaps the most noxious of the myriad entanglementsSheikh Tahnoon bin Zayed Al Nahyan — an Abu Dhabi prince known as the “spy sheikh” for his leadership of the UAE’s intelligence service — secretly agreed to buy a huge stake in a crypto company partially owned by the president and his family, paying $500 million in what The Wall Street Journal described as a “hugely profitable” deal for its founders.

The dealing is so egregious that it even raised eyebrows in Trump-friendly circles. “You know what the difference is between the Biden family business and the Trump family business?” Fox News contributor Andrew McCarthy asked in a February piece for National Review. “You’d have to add two digits to the sum of Biden abuses of power, foreign entanglements, and corruption alleged in the report to get near what Trump has raked in just from the UAE.”

But that’s just one of numerous business deals in the Gulf involving the president’s family.

The network’s evening programs have mentioned the Trump family’s myriad Gulf state conflicts just twice since late last year.

The Trump Organization, which the president owns and Eric and Don Jr. oversee, is partnering with a developer who has ties to the Saudi government on a series of Trump-branded real estate projects in Saudi Arabia, the UAE, Qatar and Oman — including a $7 billion development deal financed by the Saudi Arabian Public Investment Fund, whose board of directors is headed by Saudi Crown Prince Mohammed bin Salman.

Kushner’s private equity fund received a $2 billion investment from the Saudi PIF — reportedly forced through by bin Salman over the board’s objection — as well as $200 million from the UAE.

The Qatari royal family gave Trump a $400 million “super luxury Boeing 747-8 jumbo jet” to serve as Air Force One.

The Associated Press reports that Powerus, a Florida-based drone manufacturer partly owned by Don Jr. and Eric, is reportedly “trying to sell” defensive drone interceptors “to Gulf countries while they are under attack by Iran and dependent on the U.S. military led by their father.” (Powerus co-founder Brett Velicovich told the AP that the company “is doing many demos across the Middle East right now” but did not name the specific countries.)

The Trumps and the White House claim that all of these actions are above board.

In December 2024, Eric said of potential conflicts of interest, “I have no interaction with Washington, D.C. I want no interaction with Washington, D.C.” Don Jr. denied trading on his father’s name in a May 2025 statement to The New York Timessaying, “It’s laughable that the left-wing media thinks that I should lock myself in a padded room while my father is president and cease doing what I’ve been doing for over 25 years to earn a living and provide for my five children.” In an October 2025 CBS News interview alongside Middle East special envoy Steve Witkoff, Kushner brushed off ethical concerns, saying, “What people call conflicts of interests, Steve and I call experience and trusted relationships that we have throughout the world.” And in November 2025, White House press secretary Caroline Leavitt denied the president and his family are compromised by business interests, insisting it is “frankly ridiculous that anyone in this room would even suggest that President Trump is doing anything for his own benefit.”

For Fox News, their word is apparently sufficient. The network’s evening programs have mentioned the Trump family’s myriad Gulf state conflicts just twice since late last year.

In the first instance, Jessica Tarlov, the Democratic co-host of the panel show “The Five,” raised the issue of “Donald Trump and his family, their corruption” while discussing the president’s poor polling performance during a Feb. 10 segment about the midterm elections.

“This story [Fox contributor] Andy McCarthy is doing a series for the National Review on it,” she said. “All the crypto money that they’re taking in from the [United Arab Emirates] and others is a really big deal.”

The only other Fox News mention of the Trump family’s conflicts of interest in the Gulf that our study found came during a segment on Trump’s planned presidential library-hotel that aired on the network’s flagship, ostensibly straight news broadcast, “Special Report.”

“Guests will be welcomed into the lobby by Air Force One, presumably the Boeing 747 gifted by Qatar,” Fox correspondent Aishah Hasnie said during the March 31 news package.

When an interviewer asked “Special Report” anchor Bret Baier last year if the news media should provide the business dealings of Trump’s sons with the same scrutiny they gave those of Hunter Biden, he replied, “100%.”

“If you’re going to play it one way, you’ve got to play it another way and you’ve got to cover all of those things,” he said.

But that’s not how things have played out on Baier’s network, even with the alleged corruption far more direct, the sums vastly larger and the potential consequences far more dire.

Matt Gertz

Matt Gertz is a senior fellow at Media Matters for America, a progressive research center that monitors the U.S. media. His work focuses on the relationship between Fox News and the Republican Party, media ethics and news coverage of politics and elections.

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