The Dictatorship

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

Published

3 weeks ago

February 20, 2026

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.

The Dictatorship

The Latest: US hits pro-government demonstration in Iran as war threatens global economy

Published

13 hours ago

March 14, 2026

Blue Light Newsroom

The Latest: US hits pro-government demonstration in Iran as war threatens global economy

The Dictatorship

Suspect in Temple Israel attack lost family in Israeli airstrikes

Published

23 hours ago

March 14, 2026

Blue Light Newsroom

Suspect in Temple Israel attack lost family in Israeli airstrikes

Mar. 13, 2026, 6:23 PM EDT

The suspect in an attack at a synagogue near Detroit lost several family members in an Israeli airstrike in Lebanon this month, according to the Islamic Institute of America in Dearborn and community leaders.

Ayman Mohamad Ghazali, a 41-year-old U.S. citizen originally from Lebanon, lost his two brothers and a niece and nephew in the strike on their home, according to those sources. Whether that played a role in the motive for the attack remains unclear, and Gov. Gretchen Whitmer deferred a question about it to the FBI on Friday, citing an ongoing investigation.

Authorities are looking at the possibility Ghazali may have had familial ties to Hezbollah in Lebanon, two law enforcement officials briefed on the investigation told MS NOW.

Ghazali died in the Thursday attack, in which authorities say he drove a car into Temple Israel in West Bloomfield, Michigan, injuring a security officer. Ghazali was a resident of Dearborn Heights, Mayor Mo Baydoun said in a Facebook post. Baydoun also said in that post that Ghazali “lost several members of his own family, including his niece and nephew, in an Israeli attack on their home in Lebanon” this month.

The Thursday attack in Michigan came as the U.S. and Israel wage a war with Iranwhich they launched on Feb. 28. Security around Jewish communities in places such as New York has been heightened since the conflict began.

Ghazali first came to the U.S. in 2011 on a spousal visa before being granted citizenship in 2016, a spokesperson for the Department of Homeland Security said.

In a phone interview with Fox host Brian Kilmeade, President Donald Trump appeared to blame former President Joe Biden for Ghazali’s entry into the country when asked about the Michigan attack and the deadly shooting at Old Dominion University in Michigan.

“They came in a lot through Biden, and they came in through other presidents, frankly, and it’s a disgrace,” Trump said.

Temple Israel describes itself as the country’s largest Jewish Reform congregation, and it also has an early childhood education center on site that more than 100 kids attend, Whitmer said. All children were safely evacuated following the attack, Oakland County Sheriff Michael Bouchard said.

“This is targeting babies who are Jewish,” Whitmer said. “That’s antisemitism at its absolute worst.”

The security guard who was injured was hospitalized but is expected to recover.

Whitmer on Friday thanked the synagogue’s security personnel, who she said “were selfless in their courage and they saved lives.”

Sen. Elissa Slotkin, D-Mich., added that if the synagogue’s private security, local law enforcement and first responders “had not all done their jobs almost perfectly, we would be talking about an immense tragedy here today with children gone.”

Andrew Bossone and Chris O’Leary contributed to this report.

Julianne McShane is a breaking news reporter for MS NOW who also covers the politics of abortion and reproductive rights. You can send her tips from a non-work device on Signal at jmcshane.19 or follow her on X or Bluesky.

Marc Santia is an investigative correspondent for MS NOW.

The Dictatorship

Missile strikes a helipad inside the U.S. Embassy compound in Baghdad, Iraqi security officials say

Published

24 hours ago

March 14, 2026

Blue Light Newsroom

Missile strikes a helipad inside the U.S. Embassy compound in Baghdad, Iraqi security officials say

Mar. 14, 2026, 12:25 AM EDT

BAGHDAD (AP) — A missile struck a helipad inside the U.S. Embassy compound in Baghdad, two Iraqi security officials said.

Associated Press footage showed a column of smoke rising Saturday morning over the embassy compound.

The sprawling embassy complex, one of the largest U.S. diplomatic facilities in the world, has been repeatedly targeted by rockets and drones fired by Iran-aligned militias.

There was no immediate comment from the U.S. Embassy in Baghdad. On Friday, the embassy renewed its Level 4 security alert for Iraq, warning that Iran and Iran-aligned militia groups have previously carried out attacks against U.S. citizens, interests and infrastructure, and “may continue to target them.”