The US Department of Agriculture is rolling back a Biden-era proposal that aimed to tighten regulations surrounding raw poultry products to reduce salmonella illnesses.
The department’s Food Safety and Inspection Service said it would withdraw the framework after public comments including from industry groups “raised several important issues that warrant further consideration,” according to an unpublished version of the proposed rule that was posted to the Federal Register. The window for public comment closed in January, attracting more than 1,400 unique letters, the USDA said.
released its first-quarter results after Thursday's closing bell. Here's a look at the details from the report.
The Details: Gilead Sciences reported quarterly earnings of $1.81 per share, which beat the analyst consensus estimate of $1.76. Quarterly revenue came in at $6.67 billion, which missed the analyst consensus estimate of $6.77 billion and is a decrease from revenue of $6.69 billion year-over-year.
For the first quarter, the company reported:
HIV product sales increased 6% to $4.6 billion in the first quarter of 2025 compared to the same period in 2024, primarily driven by higher average realized price and demand.
Liver Disease portfolio sales increased 3% to $758 million in the first quarter of 2025 compared to the same period in 2024. This was primarily driven by increased demand in products for primary biliary cholangitis, chronic hepatitis B virus and chronic hepatitis delta virus, partially offset by lower average realized price for chronic hepatitis C virus products.
Veklury sales decreased 45% to $302 million in the first quarter of 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations across regions.
Cell Therapy product sales decreased 3% to $464 million in the first quarter 2025 compared to the same period in 2024.
“Gilead had a strong start to the year driven by excellent commercial and clinical execution along with disciplined expense management,” said Daniel O’Day, Gilead’s CEO.
“Our base business grew 4% year-over-year, primarily led by Biktarvy’s continued strength, and we announced positive topline Phase 3 results for Trodelvy plus pembrolizumab in first line PD-L1+ metastatic triple negative breast cancer,” O’Day added.
Community Health Systems reported first-quarter earnings that beat analysts’ expectations on Wednesday, includingyear-over-year same store operating revenue growth of 3.1% on high demand for services and a heavier flu season.
The health system also made significant progress toward its long-term goal of deleveraging its balance sheet. CHS completed three divestitures during the quarter and announced a debt refinancing maneuver in tandem with the earnings release to bring down CHS’ debt-to-operating income ratio.
Still, familiar headwinds continued to dog the system, including elevated medical specialist fees and high rates of claim denials from payers. Uncertainties from Washington also add complexity to strategic planning, executives said, noting the Trump administration has been slow to approve state Medicaid supplemental payment programs.
The health system beat the street’s expectations for operating revenue in the first quarter, recording $3.2 billion, a 0.6% increase over last year.
The system saw asizable boost in volumes from a stronger-than-expected flu season, with same store admissions rising 4% year over year. Executives also noted an uptick in volumes from cardiac procedures and robotic surgeries, which they said pointed to the return on investment from new advanced platforms.
Operating expenses came in at $2.8 billion. CEO Tim Hingtgen told investors the company had “held the line” on supply costs and decreased contract labor costs by $8 million year over year. However, medical specialist fees increased 9% year over year to total $163 million.
CFO Kevin Hammons said CHS had planned for medical specialist fees to rise, with the majority of the increase in anesthesiology.
“It is a pain point, it continues to be a pain point,” Hammons said.
Heightened medical specialist fees were baked into CHS’ 2025 guidance, according to the CFO. CHS predicted the fees would rise 8% to 12% year over year when issuing its guidance in February, and said the system was on track with that target. Still, CHS is investing in insourcing whenever possible in hopes of bringing costs down.
CHS also completed three divestitures during the quarter, including ShorePoint Health System in Florida, Lake Norman Regional Medical Center in North Carolina and its 50% stake in Mississippi-based Merit Health Biloxi. The completed deals generated $544 million in cash proceeds for CHS, and the system estimates it will bring in $460 million more when it completes its sale of Texas-basedCedar Park Regional Medical Center later this year.
Collectively, the deals will help CHS reach a $1 billion divestiture target it set last year, Hingtgen said.
Analysts were pleased overall with the health system’s performance, despite CHS posting a $13 million net loss.
“We give [CHS] credit for continuing to execute and deliver,” Jefferies’ analyst Brian Tanquilut wrote in a Thursdaynote. Volume trends signalled fundamental improvements and management was dexterous whenadapting to expense pressures, including rising physician specialist costs.
“More important, [CHS] is executing on a hospital divestiture program that’s enabling [management] to pay down debt, just as the company is working through refinancing/extending upcoming debt maturities,” Tanquilut said.
CHS is the first for-profit health system to post first quarter earnings amid an anxious healthcare landscape. Questions are swirling about how healthcare providers could handle possible cuts to Medicaid, a brewing trade war and reduced federal funding that could torch research budgets.
Executives sought to assuage worries during Thursday’s call with investors.
“I want to acknowledge the fact that healthcare providers are currently facing a number of uncertainties,” Hingtgen said. “Navigating any potential changes that may come out of Washington in the weeks and months ahead makes planning more challenging, but our team is closely following these developments and advocating for policies that maintain and strengthen our health system.”
CHS expects to be mostly insulated from the immediate effects of tariffs, including the Trump administration’s import taxes on China, which currently sit at 145%. Hammons said less than 5% of CHS’ purchases come from China.
The majority of CHS’ supplies are purchased through a group purchasing organization, HealthTrust Purchasing Group, which offers CHS three-year fixed pricing contracts, Hammons said. The GPO sources about half its supplies through domestic suppliers.
“So we have some price protection there,” the CFO said.
Executives said they were uncertain when they would receive funding from Medicaid state supplemental payment programs. Since President Trump took office, it’s been an open question whether and when the CMS would approve payments that help health systems cover the shortfall for treating Medicaid patients.
Approvals for New Mexico and Tennessee programs — which CHS was waiting on at the close of 2024 — still have yet to be approved. However, executives were heartened by approvals of similar programs in other states, including New Hampshire and Arizona.
“It does appear that things are moving and that there’s not a complete moratorium on these plans,” said Hingtgen. “But we’re just still in a wait and see, and as we sit here today, we know of no reason that they will not be approved going forward.”
Despite CHS’ relatively strong performance and assurances issued by its leadership, Jefferies’Tanquilut said the uncertainties cast over the market put CHS’ stock in a short-term difficult position.
“We recognize that the progress CHS is making in driving operational improvements and its balance sheet are overshadowed by ongoing risks associated with broader healthcare policy,” the analyst said. “Our view is that until we see a final budget reconciliation bill this summer (that presumably will mostly be funded by Medicaid cuts, which could have a meaningful impact on hospitals), near-term stock upside/recovery will likely be limited.”
Post-hoc analysis of higher risk older adults showed substantial and sustained improvements in tardive dyskinesia symptoms with no new treatment-emergent adverse events of clinical concern
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced publication of a post-hoc analysis from two 48-week studies, the KINECT® 3 extension and KINECT® 4, demonstrating the long-term safety profile and robust efficacy of INGREZZA® (valbenazine) capsules in adults aged 65 years and older with tardive dyskinesia (TD) in TheJournal of Clinical Psychiatry. This represents the first and only published peer-reviewed analysis of a vesicular monoamine transporter 2 inhibitor for the treatment of TD in older adults (≥65 years), a group at higher risk for TD and associated consequences.
An E. coli outbreak linked to romaine lettuce ripped across 15 states in November, sickening dozens of people, including a 9-year-old boy in Indiana who nearly died of kidney failure and a 57-year-old Missouri woman who fell ill after attending a funeral lunch. One person died.
But chances are you haven’t heard about it.
The Food and Drug Administrationindicated in February that it had closed the investigation without publicly detailing what had happened — or which companies were responsible for growing and processing the contaminated lettuce.
According to an internal report obtained by NBC News, the FDA did not name the companies because no contaminated lettuce was left by the time investigators uncovered where the pathogen was coming from.
“There were no public communications related to this outbreak,” the FDA said in its report, which noted that there had been a death but provided no details about it.
Federal officials are not required by law to reveal detailed information about all known outbreaks of foodborne illnesses, and there are reasons the FDA may choose not to publicize an outbreak, including when the cause is unknown or when officials are still working behind the scenes with the companies responsible.
But the FDA had shifted in recent years toward greater transparency in the wake of large-scale outbreaks and heightened public concern about contaminated food, said Frank Yiannas, the former deputy commissioner of food policy and response at the agency.
“It is disturbing that FDA hasn’t said anything more public or identified the name of a grower or processor,” said Yiannas, who was at the FDA from 2018 to 2023.
By declining to name the culprit, he said, the FDA was withholding critical information that consumers could use to make decisions about what they buy. It’s also possible that someone could have been sickened during the outbreak and not have realized the cause, and serious bacterial illness can cause long-term damage.
Do you have a news tip you’d like to share about food safety or outbreaks of foodborne illness? You can message Suzy Khimm on Signal: SuzyKhimm.42 or contact NBC News securely here.
The FDA, which is a part of the Department of Health and Human Services, denied that its response to the recent E. coli outbreak marked any shift in policy.
“The FDA names firms when there is enough evidence linking an outbreak to a firm and there is actionable advice for consumers, as long as naming the firm is not legally prohibited,” a spokesperson said in a statement to NBC News. “By the time investigators had confirmed the likely source, the outbreak had already ended and there was no actionable advice for consumers.”
Food safety advocates argue that disclosing such information is still critical to ensure that people will dispose of contaminated food they may have frozen and stored and to allow consumers to make informed choices.
“People have a right to know who’s selling contaminated products,” said Sandra Eskin, a former official at the U.S. Agriculture Department who now works as a food safety advocate.
But much of the staff responsible for developing and distributing information to the public about foodborne illnesses was terminated this month as part of the Trump administration’s sweeping effort to shrink the federal government.
“We no longer have all the mechanisms in place to learn from those situations and prevent the next outbreak from happening,” said Taryn Webb, who led the FDA’s public engagement division for human foods until she was laid off during the mass firing this month.
And the administration has separately moved to delay a new federal rule requiring food companies and grocery stores to rapidly track down contaminated food and pull it off the shelves, though the FDA said the delay was meant to give time to ensure better compliance.
The FDA said its staff members “continue to provide critical communications to consumers associated with foodborne outbreaks,” including information about recalls and investigations.
The morning the first cases of E. coli started coming in, Dr. Amanda Brzozowski sensed something was very wrong.
It was early November, and all three were E. coli 0157:H7 — an especially dangerous strain that can result in severe illness, organ damage and, in rare cases, death — and the people sickened were all high school students who lived in the same area of St. Louis County.
Brzozowski, a senior epidemiologist for the county, immediately reached out to the school they attended, and, within hours, more families were reporting symptoms of E. coli infection: bloody diarrhea, stomach cramps, vomiting and dehydration.
Ultimately, the county Public Health Department found 115 confirmed or probable E. coli cases linked to food served by a local catering company — and that the salads they ate were a likely culprit. The catering company has declined to comment.
“It was really scary,” Brzozowski told NBC News. “This type of situation we’ve never seen before.”
The victims included 15-year-old Austin Carnaghi, who opted for more salad instead of a brownie at his marching band’s annual banquet before he developed severe stomach pain and needed to be hospitalized, according to his mother, Kristiana Carnaghi. “It was an unbelievable amount of cramping,” she said.
Austin Carnaghi became sickened with E.coli after eating a meal at a banquet for his high school marching band. Courtesy Kristiana Carnaghi
Miles away in Indiana, the same strain of E. coli had stricken another boy.
The morning after he played basketball, Colton George, 9, woke up and was doubled over in pain. His parents rushed him to the hospital, where testing confirmed the presence of E. coli 0157:H7.
He had developed hemolytic uremic syndrome, a life-threatening complication from the E. coli infection, and needed to be put on around-the-clock dialysis, without food or drink for days.
Christopher and Amber George and their son Colton, who developed life-threatening complications from an E. coli infection. Courtesy Chris George
His parents, Christopher and Amber George, tried to prepare Colton for what was happening. “Unfortunately, if we don’t do this,” his mother said she told him, “there is a chance you won’t make it.”
Colton was on dialysis in a hospital bed for two weeks — including over his 10th birthday — before he was released. Months later, he is back to playing basketball but still experiences chronic stomach pain and fatigue because of the complications.
And his parents have been wrestling with the same question ever since the doctors told them that the E. coli must have come from something Colton had eaten.
Colton George spent his birthday at the hospital after he fell ill.Courtesy Chris George
“Where did he get this from?” his father said. “Something must have gone wrong somewhere.”
Colton's parents say it wasn't just a coincidence their son had symptoms similar to those of the Missouri high-school students, around the same time and with the same diagnosis of E. coli 0157:H7.
The bacteria that infected them had the same genetic sequencing, according to a lawsuit by the Georges that alleges the tainted produce came from Taylor Farms, one of the country’s largest producers of salads and fresh cut vegetables.
Public health officials use genetic fingerprints of bacteria to help pinpoint the source of foodborne illnesses. In late November, FDA officials were alerted to a cluster of E. coli O157:H7 cases after Missouri officials investigated the cases linked to the catering company, according to the FDA’s report on the outbreak.
The genomic fingerprint of the pathogen was also posted to a national laboratory network for tracking foodborne illnesses.
That data was used to help connect 89 cases across 15 states: The youngest victim was 4, and the oldest was 90. They all first had symptoms in November; more than a third were hospitalized, and seven had developed hemolytic uremic syndrome, a disease that affects kidney function. But the number of probable cases local health officials tallied was significantly higher, since not all victims went to the hospital and had samples that were genetically sequenced, Brzozowski said.
Using the genetic analysis, local health surveys and other evidence, federal investigators came to a conclusion. “Based on epidemiologic and traceback data, romaine lettuce was confirmed as the source of this outbreak,” according to the report, which noted the contaminated produce came from “a sole processor” that had obtained the lettuce from a grower.
But the FDA redacted the name of the companies that processed and grew the lettuce before it released the report in response to a public records request filed by the Georges’ attorney, Bill Marler.
As part of the lawsuit, Marler obtained receipts, also reviewed by NBC News, that he says show the salad linked to the outbreak originally came from Salinas, California-based Taylor Farms, which supplies major supermarkets and chain restaurants across the country.
Colton was on dialysis in a hospital bed for two weeks after he developed hemolytic uremic syndrome and risked kidney failure.Courtesy Chris George
The Georges, the Carnaghis and other victims have all accused Taylor Farms in nine different lawsuits, arguing in court papers that it sold “defective and unreasonably dangerous” food products.
Taylor Farms denied that any of its products were responsible for the outbreak.
“We don’t believe Taylor Farms was the source of the referenced recent E. coli outbreaks, based on information collected during thorough third-party investigations and robust food safety controls,” it said in a statement.
After this article was published, Taylor Farms released an updated statement saying, in part, “Taylor Farms product WAS NOT the source of the referenced 2024 E. Coli outbreak. We perform extensive raw and finished product testing on all our product and there was no evidence of contamination.”
Asked whether Taylor Farms had produced the contaminated lettuce involved in the outbreak, the FDA said in a statement that it was restricted by federal law from disclosing “confidential commercial information.”
The accusations against the company come on the heels of another deadly outbreak: In October, just weeks before the St. Louis cases surfaced, Taylor Farms had voluntarily recalled yellow onions linked to a separate E. coli outbreak — one that also infected more than 100 people and killed one.
In that case, though, the FDA issued an advisory notifying the public about the contaminated onions, which were served on McDonald’s hamburgers, making headlines across the country.
Taylor Farms said it would always act out of an abundance of caution to protect consumers. It added that it had robust food safety and pathogen testing procedures and that onion samples that health officials had taken at McDonald’s restaurants had tested negative for E. coli O157:H7.
On the romaine lettuce outbreak, the FDA said only that it was investigating an E. coli O157:H7 outbreak involving 89 cases.
In mid-January, the Centers for Disease Control and Prevention declared the outbreak was over, according to a letter sent to state health departments obtained by NBC News. And in February, the FDA moved its outbreak investigation from “active” to “closed,” without providing further details, according to archived versions of its website.
The full scope of the outbreak came to light only in response to the public records requests filed bythe victims' attorneys.
Even in outbreaks without recalled products, Yiannas said, he pushed the FDA to publish more advisories describing the cases and where they occurred, the symptoms to watch for and the brands of contaminated food that were sold, as well as investigative reports detailing the FDA’s findings.
In 2022, for instance, the FDA issued public health advisories in cases of hepatitis A in fresh strawberries and E. coli in packaged salad greens, even though they were not subject to recalls and were no longer sold.
The FDA told NBC News that it had issued such statements because “consumers could have frozen product for later use” and the outbreaks were still ongoing when it pinpointed the source, unlike with the 2024 E. coli case linked to romaine lettuce.
Federal officials may also hold off on making public statements while they are privately pushing food growers and processors to change their safety practices and procedures or because elements are still under investigation, former FDA staff members said. Other times, the federal government may not have enough definite evidence to pinpoint the source of an outbreak.
It’s especially challenging for FDA investigators to hunt down and identify foodborne illness linked to fresh produce, because the products have a short shelf life compared to canned goods, which can be stored for years. Highly perishable, fresh produce is often considered out of circulation once it is no longer available for sale.
But publicly identifying the source can help pressure companies to adopt and improve practices to prevent food from being contaminated in the first place, said Barbara Kowalcyk, a professor and food safety expert at George Washington University.
E. coli cases can stem in some cases from contamination between animal waste and produce while fruits and vegetables are still being grown in fields, because of runoff from livestock farms, the design of irrigation systems or even extreme weather that results in an unexpected flooding of contaminated water.
“The whole purpose of investigating these outbreaks is to stop the illnesses and to learn how to prevent future outbreaks,” Kowalcyk said. “If you don’t come out and talk about what happened, we’ve lost that opportunity.”
And the FDA’s reticence about the romaine lettuce outbreak has angered families like the Georges, who say they are still struggling to pay off about $20,000 in medical bills while their son continues to recover. Even if that contaminated lettuce is no longer sold, they believe the public has a right to know.
“It’s not fair for them to get off the hook,” Amber George said. “People are still going out and buying their product every day and have no idea what happened.”
opens in a new tab or window, with two indications, for treating non-keratinizing nasopharyngeal carcinoma (NPC) in adults. No trade name was indicated for the drug.
The first indication -- for the first-line treatment of recurrent or metastatic disease in combination with platinum-based chemotherapy plus gemcitabine -- was based on results from Study AK105-304opens in a new tab or window. In that multicenter randomized trial of 291 patients, the addition of penpulimab to chemotherapy significantly improved progression-free survival versus placebo (median 9.6 vs 7 months; HR 0.45, 95% CI 0.33-0.62, P<0.0001). Overall survival data were immature, but "with 70% of pre-specified deaths for the final analysis reported, no detrimental trend was observed," the FDA said.
Penpulimab also landed a monotherapy indication as a third- or later-line agent for patients with metastatic non-keratinizing NPC who had disease progression on or after platinum-based chemotherapy and at least one other line of therapy. Single-agent use was evaluated in Study AK105-202
opens in a new tab or window, a single-arm trial of 125 patients. The PD-1 inhibitor in that study demonstrated an overall response rate of 28%, with a median duration of response not reached.
As for safety, immune-mediated adverse events among patients treated with penpulimab included pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin reactions.
According to the labelingopens in a new tab or window, the most common adverse events (≥20%) for penpulimab in combination with chemotherapy were nausea, vomiting, hypothyroidism, constipation, decreased appetite and weight, cough, COVID infection, fatigue, rash, and pyrexia; the most common adverse events for single-agent use were hypothyroidism and musculoskeletal pain.
Fatal adverse events occurred in 1% of patients, including one case each of pneumonitis, septic shock, colitis, and hepatitis.
