Sally Mais
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
‘Sherlock’ Creator Steven Moffat and Producer Sue Vertue on New Show ‘Number 10’: A ‘Workplace Comedy Drama in the Most Ridiculous Workplace’
‘Sherlock‘ producer Sue Vertue and co-creator Steven Moffat talked at Series Mania about their new political show “Number 10,” written by Moffat for Channel 4/ITVS.
“[It’s about] British government, we don’t know which party is in power. You have no idea. But, as I discovered in my research, it really makes no difference,” says Moffat.
“It’s not a satire. Whatever the disastrous outcome, for most part, these people are trying to get a good outcome. It’s funny and quite serious at times. I did an awful lot of research, which was usual for me, and got so many great stories about what goes on in this house. Yeah, I know they are politicians, but every proper sensible country governs from mighty buildings and castles. We got a wee street!”
“If you want to look at British self-image and what we are like as a nation, go to Downing Street. This little street. That’s us. That’s how we are. Inside, the toilets don’t often work, the lift breaks down, and in the room where they held the most important meetings, there is a sword – if everyone moves it, they’ve broken a terrible law. You will find out why if you watch the show.”
The politics has very little to do with the show, he states. Even though it was filmed on the actual Downing Street.
“As one character says, quoting a real-life Prime Minister: ‘Most of this job is trying to choose between two unacceptable outcomes.’ That’s pure drama. That’s glorious. ‘Which one of these should I chose?’ ‘It’s up to you, Prime Minister.’ ‘But they are both terrible? ‘Yes, Prime Minister.’ ‘I will be blamed for it, won’t I?’ ‘You will, Prime Minister.’ ‘Is more data coming in? Can we wait for it?’ ‘Yes, Prime Minister. No, Prime Minister.’”
“Think of it as a workplace comedy drama – in the most ridiculous workplace. The one where if you have an accidental hookup at a Christmas party, it’s going on the front page. If you have a serious hangover, you can start a war. It’s a place of high drama, sometimes high principle, but staffed by just people,” he notes.
“A lot of the stories are true. I’ve disguised the names to protect the guilty, but tons of it actually happens. It’s not about politics, because while making this show, any notion of having a political orientation went out of the window. I learnt too much. You are in a state of continuous crisis. What a perfect place to put a bunch of interesting characters in for a comedy drama.”
Vertue adds: “We are so proud of this show. We finished filming on Friday. It’s beautiful.”
A longtime couple in work and in life also talked about their partnership that spawned “Dracula” or “Sherlock” during the masterclass.
They spotted Cumberbatch in “Atonement,” where “he played a really creepy character. But he looked and sounded the part,” says Moffat.
“He had his demeanor. The BBC said: ‘He’s brilliant, just one thing: You did promise us a sexy Sherlock Holmes and he’s not, is he?’
Before Martin Freeman was cast, Matt Smith – Eleventh Doctor in “Doctor Who” – was one of the first people to audition for the role.
“Martin was a bit grumpy and we didn’t think he wanted the part. Then his agent called me: ‘No, he did, but he just had his wallet stolen’,” recalled Vertue, with Moffat adding: “They are both brilliant but I don’t know if they are ever more brilliant than when they are together.”
When they first met, Vertue was a “bigger name,” says Moffat.
“I don’t know, I guess making things like ‘Mr. Bean’ makes you famous. When we met, she was way out of my league. People ask: ‘Is it a problem, working with your wife?’ Well, raising children together is hard, too. If working together is ‘hard,’ what the hell are you doing getting married?!”
He adds: “Also, we are saving production money – we only need one hotel room.”
How did they fall in love?
“In a bar,” deadpans Vertue.
Or, rather, at the Edinburg TV festival.
“You know when you know immediately when it’s right? We did. I promised another producer not to work with him for a year, kept my promise and then I nabbed him,” she says.
They also worked together on “Coupling,” which was close to their own story, they admit.
“Whatever you write, even nonsense like ‘Doctor Who’ and ‘Sherlock,’ you write what’s in front of you. I went from being a single man to being a married man. I lived in a different place; I was ‘a couple’. The rules had to be rewritten: ‘Stop flirting with women’ – that was one,” says Moffat.
“How autobiographical [was it]? Not very. Every journalist would ask: ‘Are any characters based on you and Sue?’ ‘Yes, those with our names. You are never gonna crack Watergate, are you?’ But yes, there’s some truth in it.”
“[After we met] we said: ‘Shall we be exclusive?’ I said: ‘I just have to go and dump someone.’ Sue was dumping people for about a month, and it was so easy for her! Once someone called, she picked up and said: ‘Oh hi! Sorry, I met someone. Bye’.”
According to Moffat, “if it’s boring, stick some jokes in it.”
“Real life is funny – drama is a lie. If you are saying goodbye to the love of your life, you can’t wait for her to leave because you have to pee. These Sherlock stories? If you read the original, it’s funny. Holmes is a funny guy, making impossible deductions and Watson still managing to be astonished by it. It’s glorious stuff. [‘Sherlock’ episode] ‘A Scandal in Belgravia’ is one of my favorite things and it’s non-stop gags. You can’t be too funny, too sexy or too pretty. Always go for funny.”
He adds: “Humor is truth on speed, that’s what it is. It’s insight with velocity. We had a tradition: When Sue reads a script, I move very far from her in case I want to ask: ‘Why haven’t you laughed yet?’ People must laugh when they read the script. You must laugh before you write a line. I used to say about comedy writing: Stare at the window until you make yourself laugh, and when you do, write it down.”
Vertue says: “He does all the voices and all the parts, and he’s laughing while walking down the street. Our son would say to his friends when they were coming over: ‘Don’t worry about my dad. He’s not mad, he’s just writing’.”
World
UK counterterrorism police probe antisemitic arson attack as Iran-linked group claims responsibility
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Counterterrorism police are leading an investigation after four Jewish community ambulances were set on fire outside a synagogue in London early Monday in what authorities are treating as an antisemitic hate crime.
The attack took place around 1:45 a.m. in the Golders Green neighborhood, where Hatzola ambulances, a volunteer emergency service run by the Jewish community, were deliberately set ablaze in a synagogue parking lot, according to a statement by Detective Chief Superintendent Luke Williams of the Metropolitan Police.
“This arson attack is being treated as an antisemitic hate crime. This is a devastating incident for our Jewish communities,” Williams said. He added that while the incident has not yet been formally declared terrorism, “the investigation is now being led by Counterterrorism Policing… and all lines of enquiry remain open.”
A video circulating online purports to show Harakat Ashab al-Yamin al-Islamiyya, an Iran-linked group that has claimed responsibility for recent attacks on Jewish sites in Belgium and the Netherlands, taking credit for the London attack, according to the Jewish Chronicle.
WESTERN LEADERS MUST CONFRONT ISLAMIST-INSPIRED ANTISEMITIC VIOLENCE BEFORE IT TARGETS EVERYONE
Charred remains of ambulances belonging to Hatzola, a Jewish community organization, which were set on fire in an incident that the police say is being treated as an antisemitic hate crime, in northwest London, Britain, March 23, 2026. (Hannah McKay/Reuters)
Authorities are examining a potential link to a newly emerged group with suspected ties to Iran. “We are aware of an online claim from a group taking responsibility for this attack,” Williams said. “Establishing the authenticity and accuracy of this claim will be a priority… but it is not something we can confirm at this point.”
Alan Mendoza, executive director of the Henry Jackson Society, told Fox News Digital that the attack reflects years of policy failures in confronting Iranian activity on British soil. “Successive U.K. Governments have completely failed in their primary duty of keeping the home front safe. Iranian terrorist activity has been known about in the U.K. for years yet no significant moves have been made to ban the IRGC or restrict the ability of regime-linked entities to function within British society. We have created the conditions for terrorism to flourish,” he said.
He argued that Britain’s broader approach to the conflict with Iran — attempting to maintain distance while avoiding direct confrontation — has further emboldened Tehran. “The current policy on the war in Iran is delusional. The Government is pretending Britain is not involved. The Iranian regime does not, however, believe in neutrality and has decided its position for us: ripe for targeting.”
Joe Truzman, a senior research analyst at the Foundation for Defense of Democracies, said in a post on X that “My initial assessment is that the attack could potentially be linked to Ashab al-Yamin, an Iran-linked group that has carried out multiple attacks against Jewish institutions across Europe since the war began… Hopefully this is something different, but the possibility that the group is involved should be examined.”
ISRAEL’S NETANYAHU DEMANDS WESTERN GOVERNMENTS ACT TO BATTLE ANTISEMITISM: ‘HEED OUR WARNINGS’
Charred remains of ambulances belonging to Hatzola, a Jewish community organization, which were set on fire in an incident that the police say is being treated as an antisemitic hate crime, in northwest London, Britain, March 23, 2026. (Isabel Infantes/Reuters)
Police said they are searching for three suspects seen on CCTV pouring an accelerant onto the vehicles before igniting them. No injuries were reported, though nearby homes were evacuated as a precaution.
The attack comes amid a broader wave of violence targeting Jewish communities across Europe in recent weeks.
Scott Saunders, CEO of the International March of the Living, said the incident represents a dangerous escalation. “The arson attack in Golders Green… marks a dangerous escalation in the targeting of Jewish communities,” Saunders said. “Emergency vehicles operated by Jewish volunteer first responders were deliberately attacked… in direct proximity to a place of worship — a space that should represent safety.”
CANADA’S CARNEY UNDER PRESSURE TO ACT AFTER SYNAGOGUES SHOT AT IN LATEST ANTISEMITIC INCIDENTS
Shadow Foreign Secretary Priti Patel visits the scene after four ambulances belonging to Hatzola, a Jewish community organization, were set on fire in an incident that the police say is being treated as an antisemitic hate crime, in northwest London, Britain, March 23, 2026. (Isabel Infantes/Reuters)
“These ambulances do not only serve Jewish communities… Targeting them is an attack not only on Jewish life, but on the shared fabric of the community they serve,” he added. “Since the war with Iran began, antisemitic attacks have become more frequent, more brazen, and more direct. Jewish institutions are being singled out; synagogues, community spaces, and now even the emergency services that exist to protect Jewish lives, with a growing sense that these are legitimate targets. Following the deadly shooting in and around a synagogue in Manchester last October, where this escalation already resulted in loss of life, the attack in Golders Green makes clear that this trajectory is continuing.”
Dr. Charles Asher Small, founder of the Institute for the Study of Global Antisemitism and Policy, said the attack reflects a broader trend.
“The attack against a visible Jewish target is not an isolated act of vandalism; it is the violent fruition of a climate where Jew-hatred has been normalized and institutionalized,” Small said.
ISRAELI INTEL OFFICIAL SAYS YOUR ‘JAW WOULD DROP’ AT TERROR PLOTS PREVENTED WORLDWIDE
Men hold the flag of Israel and the pre-Iranian Revolution “Lion and Sun” flag near the scene where four ambulances belonging to Hatzola, a Jewish community organization, were set on fire in an incident that the police say is being treated as an antisemitic hate crime, in northwest London, Britain, March 23, 2026. REUTERS/Isabel Infantes (Isabel Infantes/Reuters)
“At the center of this malignancy sits the Iranian regime… which actively funds and directs the networks that view British Jewish institutions as legitimate targets,” he added.
British officials also condemned the attack.
Prime Minister Keir Starmer said, “An attack on our Jewish community is an attack on us all. We will fight the poison that is antisemitism.”
Chief Rabbi Sir Ephraim Mirvis called the incident on X “a particularly sickening assault — not only on the Jewish community, but on the values we share as a society.”
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Police secure the site near a synagogue damaged by an explosion early on Monday, in Liege, Belgium, March 9, 2026. (Yves Herman/Reuters)
“The targeting of Hatzola… is a most painful illustration of the ongoing battle between those who sanctify life and those who seek to destroy it,” he added in a statement posted March 23, 2026.
Police said there have been no arrests and urged anyone with information to come forward.
World
How the Iran war is about to hit your wallet
Strikes on gas sites in the Iran war are driving up energy costs, pushing up prices for power, food and more worldwide.
Strikes on gas sites are now part of the US-Israel war with Iran. But its effect will echo far beyond the Gulf, hitting power, food, and prices worldwide. As gas supply shrinks and costs rise, who will feel it most, and how far could the shock spread?
In this episode:
- Justin Dargin (@justindargin), Energy Expert, Middle East Council on Global Affairs
Episode credits:
This episode was produced by Marcos Bartolomé, Tamara Khandaker, Sarí el-Khalili, Chloe K. Li, Tuleen Barakat, Catherine Nouhan and our guest host, Kevin Hirten. It was edited by Sarí el-Khalili. Alex Roldan is our sound designer.
The Take production team is Marcos Bartolomé, Sonia Bhagat, Spencer Cline, Sarí el-Khalili, Tamara Khandaker, Chloe K. Li, Alexandra Locke, Catherine Nouhan, Alex Roldan, and Noor Wazwaz. Our host is Malika Bilal.
Our editorial intern is Tuleen Barakat. Our engagement producers are Adam Abou-Gad and Vienna Maglio. Andrew Greiner is lead of audience engagement. Our video editors are Hisham Abu Salah and Mohannad al-Melhem. Alexandra Locke is The Take’s executive producer.
Connect with us:
@AJEPodcasts on X, Instagram, Facebook, and YouTube
Published On 23 Mar 2026
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