Irvine police find pipe bomb in car at Chevron station after arresting 2 men on drug-related charges

• September 23, 2026

Irvine police officers investigating at a gas station after two men were seen in a car using a drug pipe got a surprise when they found a pipe bomb in the center console, prompting a response from a bomb squad Tuesday night, Sept. 23, authorities said.

Irvine police were called to the Chevron gas station at the Orchard Hills Shopping Center near Portola Parkway and Culver Drive just before 6 p.m. after a passerby saw a drug pipe in the car, spokesman Officer Ziggy Azarcon said. Officers approached two men who were inside the car and took them into custody.

While searching the car, officers found the pipe bomb in the center console, Azarcon said. The car belonged to a family member of one of the men.

Irvine police called the Orange County Sheriff’s Department’s bomb squad, which determined the device was legitimate and rendered it safe, Azarcon said. It wasn’t immediately known specifically how the pipe bomb was rendered safe.

The driver, a 56-year-old man from Simi Valley, would face a potential charge related to the pipe bomb, Azarcon said. The passenger, a 48-year-old Corona man, had an outstanding warrant in Riverside County.

Why the pipe bomb was in the car was not known, Azarcon said. Police had no information to suggest the men had a plan to use the pipe bomb.

“We’re glad that a community member saw something suspicious and gave us a call,” Azarcon said.

​ Orange County Register 

A simple row cover can save late-summer vegetables as frost threatens

• September 23, 2026

By JESSICA DAMIANO

Most of my summer vegetables are winding down now, the cooling temperatures serving as a cue that their mission has been nearly accomplished. But if frost threatens before the last of my tomatoes have turned red, I’ll drape a sheet of sheer fabric over their supporting cages to provide some warmth.

The white fabric sheets, sold as “row covers,” can be used two ways: floating, which is to say draped over plants, or hooped, which means affixing them to hoops inserted into the ground.

The latter method is more protective of fragile stems and foliage, as the hoops keep the fabric, however light, from crushing plant parts.

Row covers will also do a fantastic job of protecting cool-season vegetables, such as spinach, radishes, cucumbers, potatoes, kale and lettuces as colder weather arrives.

Consider which weight is best for your row covers

The UV-protectant sheets can’t perform miracles, of course. But they can raise the temperature around plants by up to 8 degrees F, which can mean the difference between life and death.

You’ll find row covers available in various sizes, and they can be easily trimmed to fit your needs, if necessary.

They’re also available in three weight grades. Lightweight materials offer only a couple degrees of protection, so they are primarily used as insect barriers in spring. They also allow roughly 90% of sunlight to reach plants.

Heavy fabrics provide the most warming, but block sunlight and water considerably. Their use also risks raising the temperature too high.

Medium-weight fabrics strike a balance by allowing 70% to 85% of sunlight to reach plants, and warming the surrounding air by 4-6 degrees F. That might not sound like much, but it can allow several extra weeks of growing time.

And protected brassicas (such as cabbages, broccoli and kale), leafy greens and root vegetables that survive the entire winter under covering will hit the ground running come spring, long before their spring-planted counterparts acclimate.

How to set up row covers

Drape floating covers loosely over low-growing plants and secure them by burying their edges in the soil or placing stones or bricks along the perimeter. Be sure to provide enough slack to allow for plant growth.

To protect taller or more fragile crops, buy ready-made hoops or make them yourself by bending flexible PVC piping into inverted U shapes, then inserting each end into the soil to create a frame. Drape the fabric over it. You’ll still need to secure the sheet’s edges to protect it from going airborne in the wind.

Row covers can be used over a single in-ground or potted plant, an entire row of crops or a raised bed.

Keep an eye on how the plants are growing under the row covers

With protection in place, you’ll still have to monitor your plants and weather conditions.

Assess the soil’s moisture levels periodically to ensure your plants are getting enough water.

Flowering plants that require pollination will need to be exposed to insects, so watch for open blossoms and remove covers to coincide with bloom times.

Regardless of the weight used, pull covers back on warm days to avoid “cooking” your vegetables before harvest.

Jessica Damiano writes weekly gardening columns for The Associated Press. She publishes the Weekly Dirt Newsletter. Sign up here for weekly gardening tips and advice.

For more AP gardening stories, go to https://apnews.com/hub/gardening.

​ Orange County Register 

Iran’s president delivers wartime address at UN: We have been ‘victims of terrorism’

• September 23, 2026

By FARNOUSH AMIRI

UNITED NATIONS (AP) — Iran’s president said Wednesday that his people have been “victims of terrorism” by the United States, delivering a rare wartime speech at U.N. General Assembly a day after President Donald Trump said he could “annihilate” the Islamic republic.

In a defiant speech, President Masoud Pezeshkian held up large photos of the late Supreme Leader Ali Khamenei and the more than 150 school Iranian children killed on the first days of the war.

“We have only defended ourselves. We are not terrorists,” Pezeshkian said at the General Assembly. “Our innocent people have been the targets of cowardly attacks and aggressions imposed upon our country. And we defended ourselves with utmost strength. America and Israel attacked us.”

He added of the United States: “Yes they did hit us, but we did not bend the knee.” Toward the end of his speech, Pezeshkian called out Trump by name.

“It must be understood by Mr. Trump and those who seek to bully us that we are ready for dialogue and diplomacy and negotiations without accepting the language of force,” he said.

He also said one thing that was measurably false: “We did not hit civilian populations.” Mariners and migrant workers in the region have been among the civilians killed in Iran’s attacks since the war began.

A busy 24 hours for US-Iran relations

Arriving in New York under heavy security and scrutiny, Pezeshkian — who, within Iran’s political landscape, is considered a moderate politician — addressed world leaders a day after Trump used the same stage to suggest he may “annihilate” the Islamic Republic if a deal isn’t reached soon to end the nearly seven-month war.

Hours later, Trump told reporters that his chief envoys, Steve Witkoff and Jared Kushner, met for about three hours with the Iranian officials on the sidelines of the annual gathering. But he offered few details about how the discussions transpired or the substance of the exchange.

“It was a very good meeting,” Trump said. The president later added that the Iranian officials were “not the highest level, but it’s something.” Also on Tuesday, Secretary of State Marco Rubio said Trump is open to meeting with Pezeshkian while he’s in New York.

But Tehran downplayed Tuesday’s unscheduled exchange, which were the first indirect talks between U.S. and Iranian officials since a June ceasefire unraveled. Esmail Baghaei, an Iranian Foreign Ministry spokesperson, maintained the country’s negotiating position in talks with U.S. officials, demanding that Washington end its blockade of Iranian ports and release frozen Iranian assets,

Baghaei said the talks — conducted indirectly through Qatari mediators — were “not anything new.”

More than a year of negotiations have taken place

Pezeshkian’s address elaborated on where Tehran stands as more than a year of start-stop negotiations between the two longtime adversaries have failed to produce a sustainable solution. His speech came as intermittent attacks continued in the Strait of Hormuz off Iran’s coast, where commercial shipping remained below prewar levels.

His address last year came months after the 12-day Israel-Iran war that saw the assassination of many of the Islamic Republic’s highest military and political leaders and once again broke down weeks of negotiations with the United States.

“Ladies and gentlemen, you all bore witness that this past June, my country was subjected to a savage aggression and flagrant contravention of the most elementary principles of international law,” Pezeshkian said at the time.

​ Orange County Register 

Mississippi police make 2nd arrest in death of Black woman found hanging from tree, seek 3rd suspect

• September 23, 2026

By SOPHIE BATES

JACKSON, Miss. (AP) — Police in Mississippi have arrested a second man in the death of a Black woman found hanging from a tree and have issued an arrest warrant for a third suspect.

Jackson police said late Tuesday that they arrested 25-year-old Earnest Lloyd Jr. in the death of 29-year-old Tasia Fortune, whose body was found hanging behind an abandoned home in the city on Aug. 3.

Like Fortune and the first man arrested, 51-year-old Jarques Ratliff, Lloyd is Black.

Ratliff was arrested in September on murder charges and has pleaded not guilty and remains jailed without bond.

Police said in a statement that they issued an arrest warrant for a third suspect, but gave no details about that person’s identity.

After Ratliff’s arrest, Jackson’s police chief, RaShall Brackney, said Ratliff had an “association” with Fortune, but she didn’t elaborate.

Although police haven’t suggested a possible motive for the killing or said whether they think race played a role, the case has attracted widespread attention because the manner of death recalled lynchings in the Southern state.

A Kentucky native, Fortune had four children and had been living in Jackson for about a decade, relatives said.

Her mother, Christy Spivey, said Fortune had struggled with homelessness in recent years, and she wasn’t sure where her daughter was living at the time of her death. She said her daughter had talked recently about starting a cleaning business and was trying to get her life in order.

​ Orange County Register 

Small bites from the UN: Music, a walkout and fighting gang violence

• September 23, 2026

UNITED NATIONS (AP) — Donald Trump spoke and made the diplomatic rounds. The U.N. secretary-general gave his final opening speech. And on the grounds of the United Nations, Greenland entered a bit of a new era.

On Wednesday, Iran’s president spoke and a Security Council meeting on artificial intelligence convenes.

But there’s lots more unfolding.

While leaders from some of the world’s most powerful nations get most of the headlines, the U.N. General Assembly meetings, which started Tuesday, make news that touch all parts of the globe. Here are few moments that might not be the top headlines but will likely get attention in delegates’ home countries:

Cuban delegation walks out

The Cuban delegation withdrew from the session of the United Nations when President Donald Trump began talking about Cuba in his speech accusing it of being a “failed” state.

Later, Cuban Foreign Affairs Minister Bruno Rodríguez reacted on X, rejecting what he called “falsehoods” and “slanders.”

“The U.S. government is unable to accept that Cuba is, and has the right to be, a fully independent and sovereign country,” Rodríguez wrote.

“The economic blockade, including the energy siege, only threatens Cuba and the rest of the nations. It is an act of genocide and collective punishment,” he said. “We are a country of peace and we deserve peace,” he said.

A soundtrack sets the mood

There was an unusual playlist before Trump was set to sign an agreement giving the U.S. the ability to expand its military presence on Greenland.

As aides and media awaited the leaders for the signing, they listened to a cover of “Send in the Clowns.” That ballad is from the musical “A Little Night Music” and includes the lyrics:

“Sorry, my dear,

But where are the clowns?

Quick, send in the clowns.

Don’t bothеr, they’re here.”

Other tracks included “One More Night” by Phil Collins and “I Wanna Know What Love Is” by — wait for it — Foreigner. Before Trump entered, the words to Frank Sinatra’s “My Way” rang out.

No problems going up this year

At last year’s global gathering of world leaders, U.S. President Donald Trump criticized the United Nations for its faulty escalator and non-working teleprompter. This year, there were no complaints.

The sudden stop of the escalator a year ago as the president and first lady Melania Trump were riding from the U.N.’s VIP entrance up to the General Assembly hall forced them to walk part way, and and Trump’s gripes made headlines around the world last year.

U.N. Secretary-General Antonio Guterres told reporters last week that unspecified measures had been taken to avoid a repeat.

On Tuesday, the Trumps took a normal non-stop ride on the escalator. And before the president stepped to the podium in the General Assembly hall, a man stood there checking out the teleprompter.

Both worked perfectly.

Coordinating to fight gang violence

South American leaders agreed that transnational organized crime is one of the region’s greatest challenges, with the presidents of Peru, Keiko Fujimori, and Chile, José Antonio Kast, calling on the United Nations to strengthen measures against criminal organizations and to join forces in combating “terrorism.”

Chilean President Kast said for the first time in a long while, Latin American governments are truly coordinating to tackle organized crime.

“Latin America is the continent of the future, and those of us leading the continent today are ready to drive that change,” Kast said.

Chile’s president, who was backed by Trump during his presidential campaign, said recent measures have resulted in an 11.5% reduction in the homicide rate over the past six months, while warning that “the task is not finished” but rather “just beginning.”

“A safer country is a country with greater confidence. Where there is confidence, there is more growth, employment, and investment,” Kast said.

Qatar calls on Israel to leave Gaza

Qatar’s Emir Sheikh Tamim bin Hamad Al Thani said Israeli leaders were “openly advocating the displacement of Gaza’s population,” warning that such a policy would obstruct efforts to improve conditions for Palestinians.

He called on Israel to fulfill its commitments to halt operations, withdraw from Gaza and lift the blockade. Qatar has worked with Egypt and the United States to mediate the Gaza ceasefire and push for implementation of the agreement.

Honoring a 40-year career

Finland President Alexander Stubb paid tribute to Elena Kalku, an ambassador from Finland who he said has had a “wonderful 44-year career” in diplomatic service and will retire at the end of the month. She was sitting behind Stubb as he spoke, and he thanked her for her service.

“And of course, with her president speaking here, you never know whether this will be the low point or the high point of her career.” Stubb joked.

​ Orange County Register 

This year’s El Nino-driven heat could cause nearly half a million more deaths, group says

• September 23, 2026

By SIBI ARASU

BENGALURU, India (AP) — This year’s powerful El Nino and the record global heat it’s driving, along with severe droughts, wildfires and shrinking water supplies, could lead to nearly half a million more deaths worldwide by the end of February, according to a research report released Wednesday.

The grim warning by the University of Chicago-based Climate Impact Lab says that as many as 451,000 more heat-related deaths between June and the end of February could be attributed to El Nino, compared with heat deaths expected in a typical year.

The heaviest toll, the group says, is expected in poorer countries, already struggling with food insecurity and high energy costs, partly due to climate change and the fallout of the war in Iran.

Michael Greenstone, a co-founder of the group and the study’s co-author, said the heat danger will likely persist beyond February — even though this El Nino is expected to end by then. The fallout of the weather phenomenon could be felt well into next summer, he added.

The research, he said, shows that heat is most dangerous in places that are already hot and relatively poor.

“If you’re already in a hot place, the extra couple of degrees are going to be much more dangerous,” he said. Wealthier places, he added, generally have greater access to air conditioning, reliable water supplies and functioning health systems.

The study combined seasonal temperature forecasts with localized estimates of how high temperatures affect mortality across more than 24,000 regions worldwide.

Researchers estimated the additional heat-related deaths by comparing deaths expected under El Nino-driven high temperatures with deaths expected if temperatures remained similar to what they have been in the last three decades. The projected fatalities are for the entire El Nino period, from June 2026 until the end of February 2027.

The report says the Global South will see more heat-related deaths

The study by Greenstone and his colleagues also warns that the Global South — a term that isn’t geographical but a reference to developing countries in general — will bear the heaviest burden of the excessive heat.

The researchers behind the report found that the Sahel region in Africa — countries along the semiarid southern fringe of the Sahara Desert — is expected to be the hardest-hit, with about 66,800 additional deaths caused by El Nino-driven heat.

Other major hot spots include South and Southeast Asia and parts of Latin America, according to the report. The researchers project about 19,400 additional heat-related deaths across the Philippines, Vietnam, Thailand and Cambodia, as well as 19,300 in Indonesia, 15,800 in India and 13,300 in Brazil.

Heat warnings and cooling centers could prevent thousands of deaths

With such staggering numbers, there are recommended measures that governments can take, the report says. They include heat-warning systems, cooling centers, hydration stations, protections for outdoor workers, expanded hospital capacity and targeted outreach to elderly people and other vulnerable groups.

The authors also call for what they describe as anticipatory financing, so governments can move resources before dangerous heat peaks.

Abhiyant Tiwari, a heat expert at NRDC India who was not involved in the study, said the report’s projections should serve as a call to action rather than be another reason for alarm.

But while it’s one thing to have well thought-out plans — as India does — implementing these plans and raising needed funds remains a challenge, he said.

“The real measure of our preparedness is not how many heat warnings we issue, but how effectively we protect people and reduce preventable deaths,” Tiwari added.

Climate change is amplifying El Nino’s record heat

El Nino is a natural climate pattern, but this year’s unusually strong event is occurring on a planet already warmed by human-caused climate change, increasing the risks from extreme heat.

The Climate Impact Lab said global land temperatures during this El Nino could be higher by about 1.2 Celsius (2.1 Fahrenheit), producing 44% more extremely hot days than in a typical year. The report said those temperature increases may mirror conditions that climate change could make common some 20 years from now.

That’s why this El Nino could offer a preview of what’s ahead as the planet continues to warm, the report said. It’s also an opportunity for decision-makers “to see exactly where emergency actions can be taken now to save tens of thousands of lives,” the authors say.

The Associated Press’ climate and environmental coverage receives financial support from multiple private foundations. AP is solely responsible for all content. Find AP’s standards for working with philanthropies, a list of supporters and funded coverage areas at AP.org.

​ Orange County Register 

The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done

• September 23, 2026

By David Hilzenrath, KFF Health News

When the FDA was deciding whether to approve the drug Tavneos several years ago to treat a set of rare autoimmune diseases, agency experts argued that would be a mistake, according to FDA records.

One problem cited: The manufacturer had provided only “limited safety data.”

As it often does, the FDA in 2021 approved the drug with a proviso: It required the manufacturer to conduct an additional years-long safety study once the drug was on the market.

Today, like many similar “postmarket” studies mandated by the FDA, that additional study is delayed, according to a federal database. As of last fall, only 21 of the planned 300 patients had been enrolled, the FDA said in an April letter and regulatory posting.

Meanwhile, the FDA has identified dozens of cases of liver damage“possibly” or “probably causally associated” with the drug. That was one of the potential side effects the postmarket study was meant to evaluate.

Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices — and the frequent lapses in follow-through.

A KFF Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still developing a plan for the study.

As a result of delays, patients, doctors, and others could be left in a fog about the risks and benefits of the drugs or devices, even as they stake their money, their health, or their lives on the products.

Postmarket study requirements “have often proven toothless,” said cardiologist Sanket Dhruva, an associate professor of medicine at the University of California-San Francisco who has published related research.

The FDA’s reliance on postmarket studies reflects a balancing act.

Making new treatments available faster can save or improve lives, especially when patients with grim prognoses and no good options have little to lose. The full risks and benefits may be revealed only over the long term, and when therapies are used by far more people than even large clinical trials enroll.

But relying on post-approval studies to resolve questions risks exposing patients to products that do more harm than good. Whoever is paying the bills — patients, insurance companies, employers, or government health programs such as Medicare and Medicaid — can end up wasting money and rewarding manufacturers for useless or risky products.

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it’s going to lead to a lot of uncertainty,” Dhruva said.

Trump administration policy changes designed to hasten drugs through FDA review could leave more riding on postmarket studies, medical researchers say.

For example, in February, FDA leaders announced that “the default requirement” for agency approvals will be one clinical trial instead of two.

Reducing pre-approval testing “will inevitably put a lot of pressure on the post-approval system,” said Aaron Kesselheim, a professor at Harvard Medical School who has analyzed postmarket studies.

FDA officials said the new policy would “substantially reduce costs” for manufacturers and “speed drugs to market.” Writing in The New England Journal of Medicine, they denied the change would compromise safety or efficacy, saying that “erroneous conclusions may be reached even with two, three, or four studies.”

In response to questions for this article, a spokesperson for the Department of Health and Human Services, which includes the FDA, said postmarket studies can experience delays for legitimate reasons. “Assessing the significance of any delay requires a case-specific review,” said the spokesperson, Emily Hilliard.

The fact that a study is delayed “should not be treated as evidence that a product has an unresolved safety or effectiveness issue,” Hilliard said.

Amgen, the company that makes Tavneos, is still working on the postmarket research the FDA mandated, company spokesperson Alison Chartan said, adding, “We remain committed to completing this important study.”

Behind Schedule

An FDA database downloaded by KFF Health News in August tracks the progress of postmarket studies that makers of drugs or biologics— such as vaccines and gene therapies — were required to perform or promised to perform.

The database showed almost 600 were running behind schedule.

Of those, more than 250 originally had final reports due before July 31, 2026 — the date that, according to an FDA webpage, the database last had been updated.

About a third of ongoing studies were listed as delayed.

In some cases, the FDA has granted extensions. In others, it has denied them. And in rare instances, the products were discontinued before the studies ran their course.

Postmarket studies can involve clinical trials or other analyses of patient data. They can look at safety or efficacy. A product can be the subject of more than one postmarket study.

The nearly 600 delayed studies involved almost 350 products, KFF Health News found.

The FDA has defined delayed as behind the original schedule. That can mean off track or overdue.

As of August, other FDA databases tracking medical devices listed dozens of postmarket studies as behind schedule.

Products included:

The CustomFlex Artificial Iris, a prosthesis implanted in the eye in place of damaged, defective, or congenitally missing irises. The protocol for a study in children was accepted in 2019, the database said. The study was meant to follow patients for five years. According to an FDA page downloaded in August, zero patients were enrolled.

Barbara Fant of Clinical Research Consultants, to whom the FDA’s 2018 letter approving the product was addressed, said the rarity of an eye disease called aniridia poses challenges for post-approval studies. The German manufacturer, the U.S. distributor, and Clinical Research Consultants are working with the FDA to identify alternative ways to fulfill the postmarket requirements, Fant said.

“Confirming the long-term safety of the device remains a top priority for both the study team and FDA,” Fant said.

Paxlovid, a treatment for COVID. A study to assess its safety in pregnant women was originally to be completed by the end of 2024, the FDA database said. “The trial completion and final report milestones were missed,” the database said.

Pfizer, the manufacturer, is working with the FDA and remains committed to “submitting results as soon as practicable,” Pfizer spokesperson Jerica Pitts said.

The Scandinavian Total Ankle Replacement system. The device and the original protocol for the clinical trial were approved in 2009. The study was meant to include a minimum of 500 subjects, the database said, but the actual number enrolled was 142. Almost half those patients had one or more adverse events, with dozens of “reoperations,” “revisions,” or “removals,” the database said.

Rachel Colloff and Cristina Pasquino — spokespeople for Enovis, which markets STAR Ankle — did not respond to multiple inquiries. Jenny Braga, a spokesperson for Stryker, which previously sold the product, did not answer questions about the postmarket study.

Oxaydo (originally named Oxecta), a form of the potentially addictive opioid painkiller oxycodone touted as designed to deter abuse. When the FDA approved it in 2011, it required the manufacturer, part of Pfizer, to conduct a postmarket study to assess whether it reduces “misuse and abuse, and their consequences: overdose, death and addiction.” The final report was originally scheduled to be submitted in 2016.

The FDA database listing the study as delayed said the agency “issued a failure to respond letter” in 2022.

Today the issue may be all but moot.

Control of the product passed from company to company over the years until 2023, when Acura Pharmaceuticals said in a Securities and Exchange Commission filing that patents on Oxaydo would begin expiring that year and it didn’t intend to continue marketing the drug.

According to another FDA database, Oxaydo has been discontinued.

The FDA has enforcement powers and uses them “where appropriate,” HHS’ Hilliard said. She did not provide requested details, and she did not answer questions about the studies listed above.

Delay Can Pay

For manufacturers, delay can pay, Harvard’s Kesselheim said. While postmarket studies are ongoing, companies can continue to sell the products.

“Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for accelerated approval drugs with incomplete confirmatory trials past their original planned completion dates,” the HHS Office of Inspector General estimated in 2022.

The FDA can demand postmarket studies for a variety of reasons, including to address concerns that arise after a product has been approved. Some look at uses not covered by the original approval, and some are meant to shed light on serious risks that are already known.

In April, when it approved Foundayo, a weight loss drug made by Eli Lilly, the FDA required the company to conduct additional research to assess a variety of concerns, including “retained gastric contents,” “major adverse cardiovascular events,” and “drug-induced liver injury,” as well as effects of exposure during pregnancy, such as “major congenital malformations,” “spontaneous abortions,” and “stillbirths.”

The FDA said it approved the drug under the new Commissioner’s National Priority Voucher program, intended for products that “ address critical national health priorities.” The program strives for an “ ultra-fast” review, the FDA has said — one to two months, instead of six months or more with other expedited pathways.

“Postmarketing requirements and enhanced safety monitoring are a routine part of the FDA’s approach to evaluating newly approved medicines,” Eli Lilly spokesperson Kristiane Silva Bello said, “including ongoing monitoring in areas identified during clinical development.”

‘False Hope’

The FDA waded into a world of uncertainty in 2016 when it granted accelerated approval to a drug for Duchenne muscular dystrophy, a degenerative disease that primarily affects boys, disabling them at a young age and ultimately killing them.

Agency scientists had found that the drug, Exondys 51, was unproven and argued against greenlighting it.

Ellis Unger, then a senior drug evaluation official at the FDA, wrote in an internal memo that “thousands of patients and their families would be given false hope in exchange for hardship and risk.”

The manufacturer, Sarepta Therapeutics, conceded the uncertainty. “A clinical benefit of EXONDYS 51 has not been established,” it said when the drug, also known by the generic name eteplirsen, was approved.

The drug, the first FDA-approved treatment for Duchenne muscular dystrophy, targeted a subset of patients with the disease.

The FDA required Sarepta to conduct further studies and warned that it could withdraw approval if postmarket trials failed to verify a clinical benefit or were “not conducted with due diligence.”

Unger issued a warning of his own: “FDA has not succeeded in withdrawing the marketing of a single drug for lack of verification of clinical benefit following accelerated approval. The reality is that if eteplirsen is given accelerated approval, it is highly likely to remain on the market indefinitely, irrespective of whether or not efficacy is verified.”

Sarepta was originally required to submit a final report on a postmarket study by a May 2021 deadline, according to an FDA database and a 2016 FDA letter to the company.

Almost a decade after the drug was approved, and more than five years after that deadline, the study was listed in an FDA database as delayed.

“The final report milestone was missed, because the sponsor requested milestone extensions due to study delays,” the database said.

Meanwhile, in 2022 the website Pharmaceutical Technology ranked Exondys 51 as the second-most expensive drug in the U.S., at an annual cost of $750,000 to $1.5 million.

Last year, the drug generated$538 million in sales for Sarepta, according to a company presentation to investors.

Sarepta found it difficult to recruit patients for the postmarket clinical trial, company spokesperson Tracy Sorrentino said. The target population is small, patients were hesitant to enroll, and Sarepta was competing with other clinical trials for participants, Sorrentino said.

The study has been fully enrolled since 2023, Sorrentino said, and the company plans to provide an initial look at the data late this year.

‘Manipulated’

Amgen is the maker of the drug Tavneos. Amgen has cited similar challenges, even as Tavneos generated $459 million in global sales last year.

When an approved treatment is available, patients may be reluctant to enroll in a study in which they could be given a placebo, Amgen’s Chartan said.

The clinical trial was originally supposed to be done by the end of 2030. As of July 24, just 49 patients had been enrolled, Chartan said.

The FDA has said the study was to include 300 patients, and each patient enrolled must be followed for five years, said Hilliard, the HHS spokesperson.

Tavneos was approved to treat severe cases of a group of diseases — known by the shorthand ANCA-associated vasculitis — in which, as the Cleveland Clinic explains, the immune system inflicts potentially fatal damage on blood vessels and organs.

“As of January 2026, estimated real-world exposure” to Tavneos “exceeds 25,000 patient-years globally, consisting of over 6,500 in the United States and 19,000 abroad,” Amgen has said. (For context, one patient taking a drug for five years would amount to five “patient-years.”)

A clinical trial sponsored by ChemoCentryx to secure approval of Tavneos failed to prove it was effective, the FDA now alleges. Instead of disclosing that outcome to the FDA, company personnel “ manipulated” the results, the FDA alleged in an April letter to Amgen.

Amgen, the parent company of ChemoCentryx, has denied the results were manipulated and has said the data “ remain valid.”

Nonetheless, the European Union recently revoked its approval of Tavneos.

The FDA is trying to pull Tavneos from the market, and Amgen is fighting that effort.

The company has a lot riding on the outcome. Tavneos can cost more than $220,000 per year, according to the drug discount website GoodRx, and when Amgen acquired ChemoCentryx in 2022 for $3.7 billion, Tavneos was the only drug ChemoCentryx had brought to market.

In a June letter to the FDA, Amgen said the benefits of Tavneos outweigh the risks.

The FDA disagrees.

The FDA “can no longer conclude that there is, or has ever been, a valid demonstration of substantial evidence of effectiveness for TAVNEOS,” the agency wrote.

Citing 76 cases of DILI — drug-induced liver injury— the agency said it was “increasingly concerned about the safety profile of TAVNEOS.” Without proof of effectiveness, at least for its approved use, “the drug’s benefits cannot outweigh its known risks,” the FDA wrote.

Data reporter Maia Rosenfeld contributed to this report.

©2026 KFF Health News. Distributed by Tribune Content Agency, LLC.

​ Orange County Register 

Rise of the robot matchmaker: These singles are letting an algorithm find their perfect match

• September 23, 2026

When she’s bored, Maeve O’Connor will scroll through Bumble or Hinge, sometimes with the intention of going on a date. Sometimes, just window shopping. But because “nobody actually likes Hinge,” she decided to try something different.

On an August afternoon, O’Connor downloaded a new dating app called Known, which launched in San Diego this summer. When she opened it, her phone rang. “I’m not a real person, so just be honest,” a voice said on the other side of the line.

O’Connor, 26, squirmed in her seat. Instead of filling out a profile, users are interviewed by an AI matchmaker. The idea is to skip the paralyzing carousel of swiping and let an algorithm choose your perfect partner.

Known is coming on the scene as young adults are increasingly struggling with how to date and the social interaction required to meet potential partners. Among the half dozen users interviewed by the San Diego Union-Tribune, some have expressed unease about the dystopian premise of looking for love though an AI chatbot. Others have been remarkably candid with the platform, handing over intimate details about their desires in the hope that an algorithm can identify the person they are most compatible with.

But whatever they think of the technology itself, they are all confronting the same question: Does Known actually work?

During a 30-minute interview, the chatbot asked O’Connor about her vacation plans this summer and what she liked (and didn’t) about her ex. Some users will discuss their relationship to God. Others will share in depth details about their kinks.

The chatbot is analyzing more than just answers, it also takes note of your hesitation, inflection and laughter to really gauge who you are.

At the end of the call, Known claims to know you better than you may know yourself — thus the name.

Since launching in July, thousands have signed up for the app.

Celeste Amadon is Known’s 22-year-old co-founder and CEO. She was raised in Seattle’s tech scene by two parents who work in venture capital, watching them raise hundreds of millions of dollars for companies chasing modern-day problems.

So as she saw AI investment surge, Amadon decided to tackle the biggest problem her friends were facing: finding love.

“All of my friends are on dating apps,” she said, “but very few of them are actually going on dates.”

Amadon blames the perverse incentives of traditional dating apps, which she says profit when people stay single.

“Dating apps stopped being about meeting people and started being about optimizing yourself for the market,” Amadon says, pointing to the ironic economics of Hinge’s “rose jail” — a phenomenon where some of your best matches are kept behind a paywall.

“I’m declaring a dating state of emergency in San Diego,” Amadon said at the app’s launch party in August. She handed out flyers that diagnosed San Diego men with Peter Pan syndrome — the phenomenon where men never grow up or settle down — and the paradox of choice caused by dating apps.

During Known’s debut at Foxhill Manor, singles dressed for the Hamptons-white theme took photos next to a poster that read “San Diego is full of hot people doing nothing about it.”

And to the poster’s point, there were a lot more selfies taken at the singles party than phone numbers swapped. “It’s ingrained for men not to approach women anymore,” said Dalton Boll, a San Diego DJ who attended the party.

The launch party felt like “a junior high dance,” said Wes Evans, a 26-year-old photographer, describing how many of his friends were “too petrified” to approach the women at the party.

The advent of Known was in part inspired by this “generation of young men who have never approached women in real life, but feel really rejected by women because the (traditional) apps were designed not to work,” Amadon said.

In the decade since Tinder and Hinge came to the app store, an arms race has emerged around perfecting profiles: One app ranks your most attractive photos, another uses AI to generate more flattering ones, and a third, aptly named RizzGPT, will write your opening messages for you — assuming, of course, someone finds you attractive enough to open them.

“We’re seeing a substantial group of young adults who are single and not even really trying to date. They’re burnt out on the apps,” said Amanda Gesselman, a social-developmental psychologist at the Kinsey Institute at Indiana University, who has spent a career studying this exact phenomenon. “You’re constantly swiping, trying to start conversations, watching them fizzle out, and then going right back to swiping again.”

Known’s answer is to skip the profile altogether — the app’s tagline is “swipeless dating.”

“Do you have time to chat right now?” the bot asked O’Connor. “Let’s start with a few simple things first.” The bot started with the basics: her job, her hobbies.

Eventually they were talking about how she’s not religious but maybe a little “woo-woo” spiritual — and while she probably wouldn’t align with a Republican, she’d be interested in dating a guy who looks like the skinny, tattooed lead singer of the musical act Role Model, Tucker Harrington Pillsbury.

After 30 minutes, the bot summarized her life in a few sentences: “You come across as the kind of person who actually shows up, someone whose Saturdays are made for surfing and slow coffee.” The bot went on, sycophantically summarizing San Diego stereotypes — optimistic, loves sunshine, likes to go on walks.

The bot said her match would be someone who is “empathetic and listens.”

“Are you serious?” laughed Lucy Baker, O’Connor’s friend who overheard the phone call with the matchmaker. She rolled her eyes. “Doesn’t everyone want someone who listens?”

O’Connor hung up the phone, uploaded six photos of herself and waited — or actually, worried.

She didn’t feel like Known really knew her by the end of the call — she wanted to call back and explain what she meant — but it was too late.

The AI transcript was being summarized and sent to the algorithm to, in theory, filter for a man in San Diego who surfs, walks and listens.

Amadon pushed back and said the agent was better equipped to gauge the “je ne sais quoi” of a person through the voice interview than a typical dating profile would.

“When writing stuff down, you naturally filter yourself,” Amadon said. “A phone call is more authentic.”

At the Known launch party, a few men shared how they told their AI matchmaker what bra size they imagine their future girlfriends would have.

“I think people are overly transparent with these chatbots,” Amadon said. “You find out a good deal about the people talking in 25 minutes.”

Though O’Connor’s initial interview was in July, she has yet to be matched by the app. Amadon said that’s by design; Known is not going to set you up with someone you’re not compatible with.

But the U-T spoke to a San Diego single who had been matched.

A few weeks ago, Erica Solberg, a 32-year-old marketing executive in San Diego, remembered waking up one morning to a notification from Known.

The app showed her a 40-year-old man who worked in real estate. Scrolling through his profile, she saw a man who frequently travels to luxurious destinations. She imagined a world where they went to baseball games on weeknights and spent Sundays at car shows.

To her friends, Solberg called him “Gaslamp Guy.” San Diego natives know the type: the West Coast finance bro—loafers, unbuttoned button-ups, Ray-Bans, and a Padres hat. If she decided to go on the date, it would cost both singles $15 — “the cost of a cocktail,” Amadon said.

From there, Known took over the logistics. It coordinated a time for the date, chose the restaurant and made the reservation. The two people wouldn’t be able to message each other until the morning of the date.

On the day of her date, Solberg watched from across the street as “Gaslamp Guy” pulled up to the Little Italy restaurant in a 1994 Porsche.

“I’d probably have swiped left on him on Hinge,” she said, “but we actually had a lot in common.”

On paper, Gaslamp Guy matched a lot of her criteria. “The conversation was good, I really liked the restaurant, but nothing really happened after, so I probably won’t follow up,” she said.

There was also the fact that he still lived with his ex.

All of this, she then shared with her AI matchmaker after the date. These post-dinner debriefs are a clever way to gather more data: The AI matchmaker uses what you say about your date — and what your date says about you — to refine your profiles for the next match.

Her next match, “Mr. Mountaineer,” turned out to be very different from her first date.

Last Wednesday, she arrived at Part Time Lover, a Hillcrest spot with a reputation to match its name, and found a 6-foot, brown-eyed man waiting for her. “He had this quiet confidence,” she said, blushing.

The conversation ran four hours — 7 to 11 p.m. — ranging from favorite restaurants to a recent rock-climbing trip that had ended, memorably, with him falling 30 feet down a cliff face.

“I was like, ‘You’re not convincing me to pick up this hobby at all,’” she said, laughing. But he did persuade her to go on a second date.

Solberg told the AI matchmaker about the successful first date that led to a second. She also had a post-date debrief with a single friend and after telling her about Mr. Mountaineer, “she’s signing up, too,” Solberg said.

​ Orange County Register