Trump Action Archive

Supporting reports

• EPA approves Georgia air quality plan removing nonattainment new source review requirements — The Environmental Protection Agency finalized approval of Georgia's State Implementation Plan revision removing nonattainment new source review (NNSR) permitting requirements and emission reduction credit provisions from the state's air quality regulations. The revision follows Georgia's 2022 redesignation of the Atlanta ozone area from nonattainment to attainment status under the Clean Air Act. The EPA rejected arguments that NNSR should remain as a contingency measure despite recent ozone standard exceedances, finding that Prevention of Significant Deterioration (PSD) permitting and maintenance plan triggers provide adequate protection.
• EPA approves Kentucky's Limited Maintenance Plan for Louisville Area ozone standards — The Environmental Protection Agency finalized approval of Kentucky's Limited Maintenance Plan (LMP) for the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS) covering the Kentucky portion of the bi-state Louisville Area (Bullitt, Jefferson, and Oldham Counties). The plan demonstrates that air quality will remain in attainment through 2027, the end of the second 10-year maintenance period following the area's 2007 redesignation from nonattainment to attainment. The EPA evaluated design value data, monitoring networks, and contingency provisions, and determined the plan adequately assures maintenance of the standard. The approval makes the plan's commitments federally enforceable under the Clean Air Act.
• EPA approves Maryland air plan revisions establishing nitrogen oxide emission limits for municipal waste combustors — The Environmental Protection Agency finalized approval of Maryland's State Implementation Plan revisions establishing reasonably available control technology (RACT) requirements for nitrogen oxide emissions from municipal waste combustors. The rule sets specific emission limits for two large facilities—Montgomery County Resource Recovery Facility (140 ppmv 24-hour average, 105 ppmv 30-day average) and Wheelabrator Baltimore (150 ppmv 24-hour average, 145 ppmv 30-day average)—and exempts small combustors constructed before August 30, 1999. The EPA rejected a commenter's request for stricter limits, finding Maryland's determinations adequate under the Clean Air Act.
• EPA approves Missouri air quality rule revisions on construction permit exemptions — The Environmental Protection Agency finalized approval of Missouri's State Implementation Plan revision modifying construction permit exemptions under the Minor New Source Review program. The rule refines emergency generator exemptions, updates recordkeeping requirements, and clarifies cross-references. EPA found the revisions comply with the Clean Air Act, do not backslide air quality, and strengthen permit exemption standards. The rule becomes effective November 9, 2026.
• EPA approves New Jersey State Implementation Plan revisions for ozone RACT certifications under Clean Air Act sections 182 and 184. — The Environmental Protection Agency issued a final rule approving New Jersey's State Implementation Plan (SIP) revisions submitted November 23, 2021, and March 3, 2025, certifying that the state meets Reasonably Available Control Technology (RACT) requirements for volatile organic compounds and nitrogen oxides emissions under the 2008 and 2015 ozone National Ambient Air Quality Standards. The approval covers the New York-Northern New Jersey-Long Island nonattainment area (Serious classification for 2008 ozone; Moderate for 2015) and the Philadelphia-Atlantic City nonattainment area (Moderate for 2015), as well as statewide Ozone Transport Region obligations. The rule becomes effective November 9, 2026.
• EPA approves Oklahoma air plan for interstate SO2 transport requirements under Clean Air Act — The Environmental Protection Agency issued a final rule approving portions of Oklahoma's State Implementation Plan (SIP) submitted May 28, 2021, demonstrating compliance with Clean Air Act section 110(a)(2)(D)(i)(I) interstate transport requirements for the 2010 1-hour sulfur dioxide (SO2) National Ambient Air Quality Standard (NAAQS). EPA determined Oklahoma's emissions will not significantly contribute to nonattainment or interfere with maintenance of the SO2 NAAQS in other states, based on weight-of-evidence analysis including certified design values, emissions trends, and source-specific evaluations within a 50-kilometer urban-scale assessment. The rule becomes effective November 9, 2026, and applies to certain areas of Indian country in Oklahoma consistent with prior SAFETEA approval and D.C. Circuit precedent.
• EPA approves clean data determination for Berrien and Muskegon County ozone nonattainment areas — The Environmental Protection Agency finalized a determination that Berrien County and Muskegon County, Michigan have attained the 2015 ozone National Ambient Air Quality Standards based on 2023-2025 monitoring data and approved exceptional events exclusions for wildfire smoke impacts. The determination suspends requirements for these areas to submit attainment demonstrations, Reasonably Available Control Measures plans, Reasonable Further Progress plans, and other State Implementation Plan requirements related to ozone attainment, contingent on continued compliance with the standard.
• EPA publishes weekly Environmental Impact Statements notice — The Environmental Protection Agency published a notice of availability for Environmental Impact Statements filed between September 28 and October 5, 2026, pursuant to Clean Air Act Section 309(a) and CEQ guidance. The notice lists two EIS actions: a draft Nuclear Regulatory Commission combined license application for the Project Matador Advanced Energy and Intelligence Campus in Texas (comment period ending November 23, 2026), and an amended APHIS draft grizzly bear damage management EIS for Montana with an extended comment period (now ending November 4, 2026). EPA's comment letters on EISs are available through the EPA's CDX database.

Supporting reports

• Food & Water Watch reports water prices up 62% in a decade — Food & Water Watch analyzed 2025 billing data from the 500 largest community water systems in the United States, which serve approximately 155 million people or 45% of the country's population. The analysis found that US households are paying 62% more for drinking water than they did a decade ago, outpacing inflation (39%), grocery prices (30%), and household income growth (19%). Water prices rose 1.6 times faster than overall inflation between 2015 and 2025, with low-income households being hit hardest.

Supporting reports

• Datacenter developers accused of circumventing EPA air pollution permitting rules — Environmental advocates allege that datacenter developers, including Amazon and Duke Energy, are manipulating EPA air pollution permitting processes by dividing emissions sources into multiple "minor" permits to avoid "major" source reviews and associated emission controls. Cases cited include North Carolina (Amazon/Duke with 649 diesel generators), New Mexico (Project Jupiter proposing two natural gas microgrids), and Maryland (four datacenters on one campus). The tactic reduces public scrutiny and regulatory oversight while potentially exposing low-income communities to increased air pollution.

Supporting reports

• Trump eliminates vehicle fuel economy standards — On September 26, Trump announced the elimination of vehicle fuel economy standards established under former President Joe Biden, continuing efforts to lock the United States into dependence on fossil fuels.
• Trump administration slashes clean car fuel economy standards — The Trump administration announced Monday the rollback of clean car rules that had required automakers to reduce emissions and improve fuel efficiency for model years 2022–2031. The Department of Transportation's new rule, called "Freedom Means Affordable Cars," reverses Biden-era standards that mandated 8–10% annual fuel efficiency increases. The administration estimates the change will reduce vehicle costs by $1,300 but will increase fuel consumption by 100 billion gallons through 2050, boost carbon dioxide emissions by 5%, and raise fuel spending by $185 billion. Environmental groups and public health advocates condemned the move.
• Trump administration finalizes rollback of federal vehicle fuel economy standards — The Transportation Department finalized a rollback of federal vehicle fuel economy requirements on Monday, reducing the projected 2031 fleetwide average from 49.3 miles per gallon to 34.9 miles per gallon. The administration projects compliance cost savings of approximately $1,289 per vehicle for automakers. However, federal projections indicate drivers will spend over $1,600 in additional fuel expenses over a vehicle's lifetime, with increased gasoline consumption and emissions.
• Trump administration eviscerates pollution limits on cars, trucks, and power plants — The Trump administration has removed or significantly weakened environmental regulations governing emissions from vehicles and power generation facilities. The article states the administration "eviscerated pollution limits on cars, trucks and power plants" as part of a broader pattern of rolling back environmental protections. This action reduces federal oversight of major sources of greenhouse gas emissions and represents a reversal of prior regulatory standards.

Supporting reports

• Law enforcement agencies diverted opioid settlement funds to surveillance technology — More than a dozen local law enforcement agencies across the country used opioid settlement money to procure Flock cameras and other AI-powered automated license plate readers. Advocates had intended the settlement funds to be directed toward underserved communities affected by the opioid crisis, not surveillance infrastructure.

Supporting reports

• Global oil prices rose amid Iran conflict escalation — Global oil prices rose for a fourth consecutive session as renewed strikes by the U.S. and Iran strained energy flows. Shipping in the Strait of Hormuz was mostly at a standstill, with the U.S. Navy blockading Iranian oil. Brent crude rose to just above $96 per barrel, up 34% since the war began. U.S. diesel prices jumped 9 cents to $5.78 per gallon, up 54% since the war began, approaching 2022 levels. U.S. gasoline prices rose to a national average of $4.14 per gallon, up 39% since the war began. Two tankers were attacked on Monday off the coast of Oman.

Supporting reports

• Trump EPA proposes rule to exempt datacenters from public air pollution disclosure — The Trump administration's Environmental Protection Agency proposed a new rule that would eliminate the Clean Air Act requirement for datacenters to publicly disclose air pollution emissions. The rule would make disclosure voluntary at state and local officials' discretion rather than mandatory. Datacenters are significant sources of nitrogen oxide, carbon monoxide, and heavy metals. Environmental advocates warn the change will reduce public oversight, prevent communities from knowing what pollutants they will breathe, and weaken enforcement of federal pollution limits linked to asthma, heart disease, and cancer.
• EPA approves two toxic datacenter chemicals despite acknowledged health risks — The Trump administration's Environmental Protection Agency approved two photoacid generator compounds for import and immediate use in U.S. datacenters, despite acknowledging in consent orders that the chemicals may present "unreasonable risk" to workers and the public and could cause sudden death, cancer, neurological damage, and reproductive harm. The EPA admitted insufficient data to quantify acute toxicity and lethality risks but approved the chemicals anyway with minimal restrictions, prompting a lawsuit by Earthjustice arguing the approval violates the Toxic Substances Control Act.

Supporting reports

• Multiple food product recalls issued for salmonella, E. coli, and Listeria contamination — Multiple food product recalls were issued in 2026 for contamination with salmonella, E. coli, and Listeria, including frozen organic blueberries sold across eight states, fresh jalapeños from Taylor Farms, 1.5 million dozen eggs sold across six states, and numerous prepared foods, salad dressings, soups, bakery items, and ready-to-eat products. FDA records show a steady stream of recalls throughout 2026, reflecting the broader food safety crisis.
• Federal funding cuts reduced food safety inspection capacity by more than 40 percent — Federal funding cuts scaled back the ability of federal agencies to conduct food inspections and provide grants to state and local health departments, reducing food safety detection systems by more than 40 percent. These cuts directly contributed to the largest cyclospora outbreak in U.S. history, with at least 9,481 people in 17 states falling ill from contaminated lettuce from Taylor Farms, and thousands more cases under investigation.

Supporting reports

• California assembly passes diaper chemical disclosure legislation — California's assembly passed legislation (68-1 vote) requiring diaper manufacturers to disclose all intentionally added chemicals on a public webpage by 2028 and on packaging by January 1, 2029. The bill addresses health risks from toxic substances—phthalates, PFAS, lead, formaldehyde, and volatile organic compounds—that accumulate in diapers worn continuously against infants' thin, absorbent skin. The measure is expected to advance to the state senate and is supported by over 150 public health groups.

Supporting reports

• FDA proposes mandatory notification system for food ingredients under GRAS pathway — The FDA submitted a proposed rule to the Federal Register on Monday requiring food manufacturers to notify the agency of all ingredients brought to market under the Generally Recognized As Safe (GRAS) pathway, closing a regulatory loophole that has allowed companies to use ingredients without formal FDA review since 1958. The Trump administration simultaneously delayed its promised definition of "ultra-processed foods," saying additional details would be shared later. Legal experts question whether the FDA has authority to mandate rather than merely request such notifications.

Supporting reports

• DOGE delayed forest-thinning grant, forests later burned — The Department of Government Efficiency (DOGE) delayed a $10 million grant that would have funded forest-thinning efforts on approximately 4,000 acres of high-risk forest in Minnesota. According to the Washington Post, most of the planned work never commenced. Subsequently, some of these same forests caught fire, suggesting that the delayed intervention may have contributed to increased fire risk or severity.

Supporting reports

• Lineage Logistics files warehouse rebuild permits amid ongoing cleanup crisis — One month after a major fire at a Lineage Logistics cold-storage warehouse in Boyle Heights, Los Angeles, the company filed applications with the city's department of building and safety to rebuild the facility to its pre-fire condition. The move drew public criticism from LA Mayor Karen Bass, who called it "a slap in the face" to residents still suffering from persistent odors from 85 million pounds of spoiled food. The city has not yet approved or denied the permits. Cleanup remains incomplete despite company assurances.

Supporting reports

• GDP growth slowed to 1.5% in Q2, below economist expectations of 2.1%, attributed to Iran war disruptions and elevated energy costs. — The Commerce Department reported Thursday that U.S. GDP grew at an annualized rate of 1.5% in the second quarter, falling short of the 2.1% rate economists had predicted. The slowdown reflects economic strain from the Iran conflict, which has disrupted shipping in the Strait of Hormuz and driven global energy costs higher. U.S. gas prices surged from $2.98 per gallon before the war to over $4 during the quarter. The first quarter had shown 2.1% growth.
• Trump administration campaign to rewrite pandemic history and restrict scientific funding — The article documents a broader Trump administration effort to rewrite the history of the Covid-19 pandemic and restrict scientific research funding. The administration has invoked the "lab leak" theory to criticize past pandemic policies while simultaneously cutting $11.4 billion in state and local health department funding. Disruptions to cancer and Alzheimer's research funding are justified as eliminating diversity, equity, and inclusion initiatives. A proposed rule would place the entire $1 trillion federal grant-making apparatus under control of political appointees, based on trials at the National Institutes of Health in 2025.
• Q2 GDP growth falls to 1.5%, below forecast — Second-quarter GDP growth came in at 1.5%, significantly below the 2.1% estimate. Trump administration officials have continued to promise 4–6% growth, creating a gap between official projections and actual economic performance.
• Treasury bond selloff follows Fed decision to hold rates steady — A selloff in Treasury bonds occurred after the Federal Reserve held interest rates steady for a seventh consecutive month. The bond market reaction suggests investor concern about inflation or economic conditions despite the Fed's decision to maintain current rates.
• U.S. GDP Growth Slows Amid Iran Conflict — The U.S. GDP grew at an annual rate of 1.5% in the second quarter, falling short of the expected 2.1% growth. The Commerce Department attributes the slowdown to the ongoing conflict in Iran, which has disrupted shipping and increased global energy costs. The economic impact is evident in rising gas prices and concerns over future growth.
• US GDP Growth Slows in Q2 2026 — The US GDP grew at an annual rate of 1.5% in the second quarter of 2026, below expectations. The slowdown is attributed to the economic impact of the conflict in the Middle East, which has disrupted shipping and increased energy costs.

Supporting reports

• Wildfires and smoke create hazardous air quality across North America — More than 800 wildfires in Canada and at least a dozen in northern Minnesota, driven by extreme weather caused by climate change, are producing smoke that exposes Americans from the Midwest to the Northeast to hazardous levels of air pollution. Detroit, Minneapolis, and Chicago rank in the top five most polluted cities in the world. New York City officials are distributing N95-type masks to commuters. More than 115 million people are in the plume of unhealthy to hazardous air quality, with conditions expected to worsen. The Trump administration has dismissed addressing climate change as a "scam."
• Canadian wildfire smoke degraded air quality in Northeast before World Cup final — Smoke from more than 100 uncontrolled fires in Canada blanketed the Northeast and Midwest with unhealthy air quality, occurring just as New Jersey prepared to host the World Cup final outdoors on July 20, 2026. The environmental degradation affects public health and major international sporting events.

Supporting reports

• Strategic Petroleum Reserve approaches depletion — The Strategic Petroleum Reserve is on the verge of hitting critically low levels within days, even as the Trump administration continues to escalate military conflict. The depletion of the reserve during an active military crisis creates vulnerability in U.S. energy security and capacity to respond to further emergencies.

Supporting reports

• Trump administration discourages antidepressant use — The Trump administration, led by Health Secretary Robert F. Kennedy Jr., has been actively discouraging the use of antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs). This campaign aligns with the Church of Scientology's long-standing opposition to psychiatric medications. On May 4, 2026, the Department of Health and Human Services announced initiatives to reduce "psychiatric overprescribing" and promote non-medication treatments. The American Psychiatric Association criticized this approach, arguing it oversimplifies the mental health crisis and ignores barriers to comprehensive care. Kennedy's financial ties to a Scientology-linked law firm further complicate the administration's stance.

Supporting reports

• New York ended health coverage for 450,000 residents — Coverage ended July 1 for nearly 450,000 New Yorkers enrolled in the state's Essential Plan, a consequence of federal Medicaid cuts in last year's budget law and the expiration of subsidies that made Affordable Care Act plans affordable. The Essential Plan served people earning too much for Medicaid but too little for private insurance, leaving them without coverage options.
• Nearly 500,000 New Yorkers lose health insurance due to HR 1 cuts — On 1 July 2026, nearly 500,000 moderate-income New Yorkers were removed from health insurance coverage as a direct result of the One Big Beautiful Bill Act (HR 1), signed into law in 2025. The law slashed $911 billion in federal health spending nationally, including elimination of New York's "essential plan" that covered residents earning 200–250% of the federal poverty level with zero-premium, low-cost coverage. State lawmakers failed to secure replacement funding in June 2026. Nationally, the law is projected to cause 10 million additional uninsured Americans over the next decade, with New York City alone expecting over 250,000 residents to lose coverage.

Supporting reports

• Arizona SNAP Enrollment Plummets Due to Federal Policy Changes — Arizona has seen a dramatic decrease in Supplemental Nutrition Assistance Program (SNAP) enrollment, with numbers dropping from 910,000 in June 2025 to 452,000 in May 2026. This decline follows the implementation of President Trump's "Big Beautiful Bill," which significantly cut federal funding for SNAP. The bill reduced the federal contribution to administrative costs from 50% to 25%, prompting Arizona to reduce staffing and create a backlog in application processing. Additionally, the state faces potential financial liability due to high error rates in SNAP benefit distribution, leading to stricter eligibility requirements and further enrollment barriers.

Supporting reports

• U.S. Strategic Petroleum Reserve falls to lowest level since early 2024 — The U.S. Strategic Petroleum Reserve fell to 357 million barrels, an 8 million barrel decline, reaching its lowest level since early 2024 and approaching levels not seen since 1983, per GasBuddy's Patrick De Haan.
• U.S. crude oil inventories fall to critical levels with industry warning of catastrophic price spikes — Politico reported that the oil industry is privately warning the Trump administration that U.S. crude stocks have fallen eight consecutive weeks and are now 3% below the five-year average. Gasoline stocks are 5% below average. Total U.S. commercial petroleum inventories are down 52 million barrels since the war began. The Strategic Petroleum Reserve was tapped for 8 million barrels last week, bringing it near its July 2023 low. Exxon's Senior VP warned Brent crude could hit $150–$160 per barrel. Gas is already at $4.26 nationally, $1.28 higher than before the war. Industry executives warned of "tank bottom" conditions and potential catastrophic price spikes by mid-to-late June. The White House denied receiving private industry warnings.
• U.S. crude oil stocks fell to lowest level in two decades — According to Financial Times reporting and U.S. government data, crude and petroleum product stocks fell by 10.6 million barrels in one week to 1.57 billion barrels—the lowest level since 2004. The Trump administration has been draining strategic petroleum reserves to contain surging prices caused by the Iran war. Industry analysts warned that oil prices are poised to rise sharply again within weeks. Bob McNally, president of Rapidan Energy Group, warned that prices could reach $200 per barrel this summer unless the Strait of Hormuz was reopened, and cautioned that such prices could trigger economic and financial system instability.
• U.S. oil reserves at lowest level in twenty-two years — According to reporting by Jamie Smyth of the Financial Times on June 4, 2026, U.S. oil reserves have fallen to their lowest level in twenty-two years. The administration released reserves to attempt to control oil prices that have skyrocketed following Trump's war on Iran, which prompted closure of the Strait of Hormuz, through which approximately 20% of the world's oil passed before the conflict. Oil industry analysts warned that prices will rise further if the crisis is not resolved.

Supporting reports

• FDA Commissioner Marty Makary resigns over flavored vape reversal — FDA Commissioner Marty Makary reportedly resigned in protest after Trump directed him to reverse the FDA's prohibition on fruit-flavored vapes. The reversal occurred within a week of Trump's meeting with Reynolds American executives and lobbyist Brian Ballard, who had complained about the ban. The fruit-flavored vape ban had been implemented to protect children from the appeal of flavored nicotine products.

Supporting reports

• FDA issues guidance opening door to flavored vape sales after tobacco donation — The Trump Food and Drug Administration issued new guidance opening the door to the sale of flavored vapes after a tobacco company donated $5 million to the Trump-backed super PAC MAGA Inc. Two days after the donation, Trump had lunch with tobacco industry representatives, during which he complained to administration officials about FDA e-cigarette regulations. The new guidance was issued days later.

Supporting reports

• Trump administration loosened federal refrigerant rules for HFCs — On Thursday, the Trump administration loosened federal refrigerant rules for grocery stores and air-conditioning companies, easing limits on hydrofluorocarbons (HFCs). Trump presented the change at a White House event as a way to reduce grocery prices. Industry and environmental critics noted that HFCs are potent climate pollutants and that some U.S. companies had already invested in alternatives the rule was designed to encourage, making the rollback economically and environmentally counterproductive.
• White House issues fact sheet on EPA refrigerant rule revisions and compliance deadline extensions — The White House issued a fact sheet announcing that President Trump terminated Biden-era refrigerant regulations through EPA revisions to the 2023 Technology Transitions Rule, extending compliance deadlines for hydrofluorocarbon use, and proposing corrections to the 2024 Emissions Reduction and Reclamation Rule to relax leak repair requirements. The fact sheet claims these actions will save Americans $2.4 billion total, preserve over 350,000 jobs, reduce food prices, and lower operating costs for supermarkets, air conditioning systems, semiconductor manufacturing, and medical supply transportation.
• Trump held an Oval Office press conference announcing a deregulation plan for grocery store refrigeration systems as an affordability measure while dismissing concerns about Senate Republican opposition to other administration priorities. — Trump held an Oval Office press conference to announce a plan to lower grocery prices through deregulation of refrigeration systems in grocery stores. When questioned about Senate Republican backlash to the weaponization fund and other priorities, Trump stated he did not know if he was losing control of the Senate and claimed he "only does what's right." The press conference reflected ongoing tension between the White House and GOP Senate leadership over fiscal and policy priorities.

Supporting reports

• White House announces National Drug Control Strategy amid contradictory policy cuts — In May 2026, the White House announced an ambitious National Drug Control Strategy that expands access to naloxone, treatment, and drug-interdiction technology, including wastewater surveillance. However, the strategy is contradicted by simultaneous budget cuts and defunding of harm-reduction tools. Former officials and experts note the strategy cannot be implemented if Congress does not reject the proposed $10 billion in cuts, and the emphasis on wastewater surveillance is undermined by the defunding of individual drug-checking tools like test strips.
• White House proposes $10 billion cut to addiction and overdose prevention funding — In April 2026, the Trump administration proposed budget cuts totaling $10 billion in federal funding for addiction treatment, overdose prevention, and related research, according to the Drug Policy Alliance. The cuts directly contradict the administration's May announcement of a National Drug Control Strategy that claims to expand access to naloxone and treatment. Public health experts and former officials note the cuts would force hospital closures and reduce addiction treatment availability, making the stated strategy impossible to implement.

Supporting reports

• EPA extends postponement of TCE regulatory provisions pending judicial review — The Environmental Protection Agency issued a notice extending the postponement of effectiveness for conditions imposed on trichloroethylene (TCE) uses granted TSCA section 6(g) exemptions under a final rule issued December 17, 2024. The postponement, originally set to expire May 18, 2026, is now extended indefinitely until conclusion of judicial review in the U.S. Court of Appeals for the Third Circuit. This marks the sixth extension since the rule's initial January 2025 effective date, following multiple industry petitions for stay and ongoing litigation.

Supporting reports

• FDA proposes withdrawal of TAVNEOS (avacopan) drug approval due to data manipulation and lack of efficacy evidence — The Food and Drug Administration's Center for Drug Evaluation and Research issued a notice proposing to withdraw approval of TAVNEOS (avacopan) capsule, 10 mg, held by ChemoCentryx, Inc. (now owned by Amgen), based on evidence that unblinded study personnel manipulated endpoint results in the pivotal ADVOCATE clinical trial after the initial database lock revealed non-significant results. The original November 5, 2019 analysis showed a p-value of 0.1025 (not statistically significant); after selective readjudication of nine subjects by unblinded personnel, the reanalyzed results showed p=0.0132 (statistically significant). The FDA found the application contained untrue statements regarding database locks and analyses, and identified serious post-market safety concerns including hepatotoxicity and vanishing bile duct syndrome. The applicant may request a hearing by June 1, 2026, with supporting data due by June 29, 2026.