WASHINGTON (AP) — Federal health officials posted a warning Tuesday about misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong, who recently told podcast listeners that his company's bladder cancer drug may be able to treat, cure or even prevent other types of cancers.
The warning letter from the Food and Drug Administration takes issue with a TV advertisement and a separate podcast episode promoting Anktiva, the lead product of ImmunityBio Inc. The drugmaker is one of several biotech firms acquired by Soon-Shiong, who also owns the Los Angeles Times.
Company shares fell more than 21% in trading Tuesday to close at $7.42 after the FDA letter posted online.
Anktiva was approved by the FDA in 2024 for patients with a hard-to-treat form of bladder cancer. ImmunityBio has been working to win FDA approval to expand the drug's use to a number of other conditions, including forms of lung and pancreatic cancer.
Soon-Shiong's controversial statements came during a January episode of “The Sean Spicer Show” podcast titled “Is the FDA blocking life-saving cancer treatments?”
At one point during the interview, Soon-Shiong described his company's drug as “the most important molecule that could cure cancer.” A few minutes later, Soon-Shiong — who is the company's executive chairman and chief medical officer — said that while the drug is approved for bladder cancer, “it actually can treat all cancers.”
Later in the episode he said, “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.”
FDA regulators said the statements violate federal drug marketing rules because they “create a misleading impression” of the drug.
Regulators also noted that the podcast didn't contain any information about risks and side effects of the drug, which can include urinary tract infections, pain, chills and pyrexia. Under FDA law, drug promotions are required to give a balanced view of a drug's risks and benefits.
The FDA warning, addressed to ImmunityBio CEO Richard Adcock, raises similar concerns with a TV advertisement for Anktiva. Both the ad and the podcast refer to the company's drug as a “cancer vaccine,” which the FDA said is false.
The letter gives the company 15 days to correct the problems and respond to the agency in writing about its plans to comply. By Tuesday afternoon, a link to the podcast had been removed from ImmunityBio's website.
Sarah Singleton, spokesperson for Culver City, California-based ImmunityBio, said via email that the company takes the FDA’s warning “very seriously,” and plans to “work cooperatively with the agency to address the matters raised in the letter.”
Under the Trump administration, the FDA has stepped up warnings against drugmakers as well as online pharmacies, including appearances by company executives on TV shows and podcasts.
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.
FILE - Pharmaceuticals billionaire Dr. Patrick Soon-Shiong waves as he arrives in the lobby of Trump Tower in New York for a meeting with President-elect Donald Trump on Jan. 10, 2017. (AP Photo/Evan Vucci, File)
NEW YORK (AP) — Commuters in New York City’s suburbs navigated a gauntlet of car, bus and subway routes to get to work Monday as a strike on the Long Island Rail Road that shut down the nation’s busiest commuter rail system entered its third day.
Unions representing rail workers and the Metropolitan Transportation Agency, which runs the railroad, negotiated for much of Sunday, wrapping their talks around 1 a.m. Monday.
But they failed to reach an agreement despite pressure from the National Mediation Board and New York Gov. Kathy Hochul. The two sides returned to the bargaining table Monday.
Katie Dolgow, who teaches first graders in Manhattan, said it had already taken her an hour just to travel from Long Island to Queens as more commuters turned to the region's already notoriously gridlocked roads. But her big concern was going home.
“I have to get my son at daycare by 5:30. It's going to take me longer getting home. I'm a teacher, I'm going to have to leave work at 1:30,” she said.
Unionized workers were out early picketing in front of major LIRR hubs, chanting slogans and holding up signs that read: “No contract. No work,” and “Equal work. Equal pay.”
“We're just asking for a reasonable cost of living adjustment on our wages,” Byron Lee, a locomotive engineer, said outside Penn Station in midtown Manhattan. “People think that we don't deserve it.”
The LIRR serves hundreds of thousands of commuters who live along a 118-mile-long (190-kilometer-long) land mass that includes Brooklyn and Queens in New York City and the Hamptons, a summertime playground for the rich and famous.
The strike started at 12:01 a.m. Saturday after five unions representing about half the rail system's workforce walked off the job. It's the first walkout for the LIRR since a two-day strike in 1994.
The unions, which represent locomotive engineers, machinists, signalmen and others, have said more substantial raises are warranted to help workers keep up with inflation and rising living costs. The MTA has said the unions’ initial demands to raise salaries would result in large fare increases and be disproportionate to other unionized workers’ pay.
“With the rate of inflation nationally, and especially in this New York area, everybody feels it,” said James Louis, vice president of the Brotherhood of Locomotive Engineers and Trainmen, on Monday. “We’re just trying to keep their heads above water. We’re not asking for anything outrageous.”
The unions and the MTA have been negotiating a new contract since 2023, but talks have stalled over salaries and healthcare.
The Trump administration got involved in September, a move that temporarily averted a strike. But months still passed without a deal.
Hochul said Sunday that workers would lose every dollar they would gain with a new contract by remaining on strike.
MTA Chairman Janno Lieber said negotiations were “headed in a positive direction” Monday morning as he dangled the prospect of LIRR service resuming Tuesday commute if a deal was reached soon.
By the afternoon, however, both sides conceded discussions were progressing slowly.
Gary Dellaverson, the MTA’s chief negotiator, on Monday afternoon said rail system officials were perhaps “overly optimistic” they could get a deal done. He said no new proposals were discussed Monday morning before union officials took a lengthy break until midafternoon.
“We continue to have optimism that we can get this done, but it’s not at the same level,” Dellaverson said outside MTA headquarters in lower Manhattan, where the two sides have been meeting. “The unions have shown us they have no sense of urgency to get this resolved.”
Ridership has been lighter than expected on the free but limited shuttle buses the MTA provided from a handful of locations on Long Island to New York City subway stations.
Officials had implored the roughly 250,000 riders who normally use the train system each weekday to work from home rather than commute into the city, if possible.
During the morning commute, more than 2,000 people took advantage of the shuttle service, the agency said. It had prepared for about 13,000 riders.
The buses are also being offered for the evening rush hour and are geared toward essential workers and those who can't telecommute.
Molloy University and Stony Brook University on Long Island are both set to hold commencements Monday.
Officials at Stony Brook urged graduates and guests to carpool where possible as the state university's ceremony was slated to start during the afternoon rush hour.
The first impacts of the walkout were felt over the weekend as baseball fans had to find other ways to get to Citi Field in Queens to see the New York Mets take on their crosstown rivals the New York Yankees.
If the strike stretches into Tuesday, basketball fans looking to catch the New York Knicks continue their playoff run could also run into problems. Madison Square Garden, where the Knicks play their home games, is located directly above the railroad’s Penn Station hub in Manhattan.
Hochul stopped by MTA headquarters in lower Manhattan on Monday morning as negotiations were underway, according to her office. The governor was briefed on the status of talks as well as the morning commute.
“She is pleased that the unions accepted her invitation to return to the table and encourages both parties to continue negotiating in good faith,” said Sean Butler, a Hochul spokesperson.
The Democrat, who is up for reelection this year, has blamed President Donald Trump’s administration for cutting mediation short in September and pushing the unions toward a strike.
McCormack reported from Concord, New Hampshire. Associated Press writers Ted Shaffrey and Joseph Frederick in New York contributed.
Signs for free Long Island Rail Road shuttle buses hang at the Howard Beach–JFK Airport station as Long Island Rail Road workers enter the third day of their strike, Monday, May 18, 2026, in New York. (AP Photo/Heather Khalifa)
Long Island Rail Road workers walk on the picket line outside of Penn Station on the third day of their strike, Monday, May 18, 2026, in New York. (AP Photo/Heather Khalifa)
A pedestrian walks along an empty track at Mineola train station as Long Island Rail Road workers strike, Monday, May 18, 2026, in Mineola, N.Y. (AP Photo/Heather Khalifa)
Tracks are empty at Mineola train station as Long Island Rail Road workers enter the third day of their strike, Monday, May 18, 2026, in Mineola, N.Y. (AP Photo/Heather Khalifa)
People exit and board buses at the Mineola train station as Long Island Rail Road workers enter the third day of their strike, Monday, May 18, 2026, in Mineola, N.Y. (AP Photo/Heather Khalifa)
Commuters sit on a shuttle bus as Long Island Rail Road workers strike, Monday, May 18, 2026, in Mineola, N.Y. (AP Photo/Heather Khalifa)
Visitors look out at the trains at the West Side Yard from the Vessel on the first day of a Long Island Rail Road workers' strike, Saturday, May 16, 2026, in New York. (AP Photo/Heather Khalifa)
Tracks are empty at Mineola train station as Long Island Rail Road workers enter the third day of their strike, Monday, May 18, 2026, in Mineola, N.Y. (AP Photo/Heather Khalifa)
