The expanded FDA approval allows Pluvicto to be used in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) who have not yet undergone androgen receptor pathway inhibition or chemotherapy, according to Novartis officials. This approval covers metastatic castration-sensitive prostate cancer (mCSPC) and metastatic androgen pathway modulation–naive/sensitive (mAPMN/S) disease, broadening the therapy’s use beyond its prior authorization for metastatic castration-resistant prostate cancer (mCRPC). Novartis representatives said the new indication nearly doubles the number of patients eligible for Pluvicto in the United States, reflecting the larger population of hormone-sensitive metastatic patients compared with those in later-stage castration-resistant disease.

Pluvicto reduced the risk of disease progression or death by 28% in the primary analysis (hazard ratio [HR] 0.72; 95% confidence interval [CI], 0.58–0.90).

The FDA’s decision on July 31, 2026, was based on results from the Phase III PSMAddition trial, which evaluated Pluvicto combined with standard of care—an androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT)—against standard of care alone. According to trial data presented by Novartis, An updated analysis showed an even greater risk reduction of 33% (HR 0.67; 95% CI, 0.55–0.82). Overall survival data indicated a positive trend favoring Pluvicto plus standard of care (HR 0.80; 95% CI, 0.63–1.01), though the final overall survival analysis is pending, Novartis officials said.

Pluvicto (lutetium Lu 177 vipivotide tetraxetan), also known as 177Lu-PSMA-617, is a targeted radioligand therapy that delivers beta-emitting lutetium-177 directly to prostate-specific membrane antigen (PSMA)–expressing prostate cancer cells. The therapy requires confirmation of PSMA-positive disease via FDA-approved PSMA PET imaging agents, such as Locametz (gallium Ga 68 gozetotide), consistent with prior labeling requirements. The recommended dosing for the mCRPC indication is 7.4 gigabecquerels (200 millicuries) administered intravenously every six weeks for six doses or until disease progression or unacceptable toxicity, according to FDA prescribing information.

Pluvicto was first approved by the FDA on March 23, 2022, for adults with PSMA-positive metastatic castration-resistant prostate cancer who had previously received both androgen receptor pathway inhibition and taxane-based chemotherapy. That approval was supported by the Phase III VISION trial, which demonstrated significant improvements in overall survival and radiographic progression-free survival. In VISION, Pluvicto plus best standard of care yielded a median overall survival of 15.3 months compared with 11.3 months in the control arm (HR 0.62; 95% CI, 0.52–0.74). Approximately 30% of patients treated with Pluvicto showed an overall response by RECIST 1.1 criteria, compared with 2% in the control group, records show.

On March 28, 2025, the FDA expanded Pluvicto’s indication to include adults with PSMA-positive mCRPC who had received ARPI therapy and were appropriate to delay taxane-based chemotherapy. This earlier use was supported by the Phase III PSMAfore trial, which showed that Pluvicto reduced the risk of radiographic progression or death by 59% compared with switching ARPI therapy (HR 0.41; 95% CI, 0.29–0.56; p<0.0001). Updated analyses from PSMAfore indicated that Pluvicto more than doubled median radiographic progression-free survival to 11.6 months compared with 5.6 months for ARPI change, according to trial investigators.

The 2026 approval for hormone-sensitive metastatic disease builds on these prior expansions by moving Pluvicto earlier in the metastatic prostate cancer continuum. Novartis officials described this as advancing a potential new standard of care across PSMA-positive metastatic prostate cancer. Industry sources and academic reviewers have noted that the shift allows for radioligand therapy to be integrated before chemotherapy in mCRPC and now in hormone-sensitive metastatic settings, potentially altering treatment sequences.

Patient selection for Pluvicto requires PSMA-positive metastatic disease confirmed by approved imaging. For the expanded mCRPC indication, patients must have prior ARPI exposure and be clinically appropriate to delay taxane chemotherapy. The therapy’s targeted mechanism offers precise tumor delivery with reduced systemic toxicity compared with conventional systemic treatments, according to peer-reviewed analyses cited by Novartis and academic experts.

The Prostate Cancer Foundation has highlighted the significance of earlier Pluvicto use, noting that about half of mCRPC patients do not survive long enough to receive second-line therapies, underscoring the need for effective treatments earlier in the disease course. The foundation described the 2025 expanded approval as allowing use before chemotherapy to slow disease progression and maintain quality of life.

FDA communications and Novartis statements confirm that Pluvicto’s expanded indication now covers adults with PSMA-positive metastatic prostate cancer across both hormone-sensitive and castration-resistant stages. The therapy’s availability throughout the metastatic disease spectrum marks a shift from end-stage treatment to earlier intervention. The final overall survival data from the PSMAddition trial are anticipated to provide further clarity on long-term benefits in the hormone-sensitive setting.

The recall covers three specific lots of dabigatran etexilate capsules, a generic blood thinner that serves as an alternative to the brand-name drug Pradaxa. All three lots share an expiration date of April 30, 2027, and were distributed nationwide in the United States in a total of 5,460 cartons, containing 299,520 capsules, according to the Food and Drug Administration’s recall database.

The affected products include 150 mg capsules in 60-count blister packs, lot number 25141583; 75 mg capsules in 60-count blister packs, lot number 25141585; and 75 mg capsules in 30-count blister packs, lot number 25141586.

The capsules were manufactured by Alkem Laboratories Ltd., based in Mumbai, India, and distributed by Major Pharmaceuticals of Indianapolis. The recall was initiated voluntarily by Alkem Laboratories following stability testing that revealed the products failed to meet impurity and degradation specifications. Specifically, FDA testing found levels of Impurity II, Impurity III, and total impurities exceeding the acceptable limits for the medication, officials said. The FDA has not yet assigned a formal risk classification to this recall.

Dabigatran etexilate is prescribed to reduce the risk of stroke and blood clots, particularly in patients with nonvalvular atrial fibrillation. The drug is a direct oral anticoagulant and is widely used across the country. Records show that more than 5,000 prescriptions may have been affected by this recall. Medical experts caution that patients should not stop taking the medication abruptly, as sudden discontinuation of blood thinners can increase the risk of stroke or thrombotic events. Patients are advised to continue their therapy until consulting with a healthcare provider, according to FDA guidance and statements from health officials.

Pharmacies and distributors holding the recalled lots are expected to halt dispensing the product and follow instructions from the FDA and the manufacturers for returning or quarantining the affected inventory. Consumers who believe they have the recalled medication are urged to contact their pharmacist or healthcare provider for verification. The FDA’s MedWatch program provides a channel for reporting adverse events or quality concerns related to the recall.

This recall is distinct from a previous nationwide recall involving dabigatran etexilate capsules distributed by Ascend Laboratories. That earlier recall, which covered 10 lots with expiration dates in May and June 2024, was prompted by the presence of nitrosamine impurities such as NDMA and N-nitroso-dabigatran above FDA’s acceptable daily intake limits. The Ascend recall, announced in 2022, also involved 75 mg and 150 mg capsules but was unrelated to the current Alkem Laboratories recall. The FDA and consumer advocacy groups noted that long-term exposure to nitrosamines may increase cancer risk, but the agency advised patients to continue their medication until consulting a healthcare professional.

The current recall reflects ongoing monitoring of drug quality and manufacturing standards by the FDA. While no adverse clinical events have been documented in connection with the Alkem Laboratories lots, the agency’s action aims to prevent potential risks associated with impurity levels exceeding specifications. Media reports from outlets such as Yahoo News and AOL have detailed the recall, including the lot numbers, expiration dates, and company information, citing the FDA recall database.

The FDA continues to oversee the recall process and will update the public if additional information or risk classifications become available. Meanwhile, patients and healthcare providers are encouraged to maintain communication to ensure safe management of anticoagulation therapy.

The Minnesota Department of Health (MDH) has identified 110 cases of Salmonella Javiana linked to the outbreak, which affected individuals who ate at Mexican-style quick-service restaurants, with a strong association to Chipotle. Medus said the cases were confirmed to be related through whole genome sequencing, a laboratory method that strengthens the epidemiological link.

Among 84 patients interviewed, 75 reported eating at Chipotle between June 14 and July 14, with most exposures occurring between June 24 and July 2, according to Carlota Medus, senior epidemiologist supervisor in MDH’s Foodborne Diseases Unit.

Chipotle responded by removing jalapeños from all Minnesota locations that received the suspect product. The company initiated its ingredient traceability system immediately after learning of the outbreak and identified jalapeños from a common lot as a potential source. Chipotle then replaced the jalapeños with peppers from different growers as a precaution, Laurie Schalow, Chipotle’s chief corporate affairs and food safety officer, said. Schalow described the company’s traceability system as robust and emphasized its cooperation with public health authorities.

MDH officials confirmed that Chipotle fully collaborated with the investigation by providing records and removing suspected jalapeños from affected restaurants. Medus noted that while the chain’s mitigation steps help prevent further transmission, it is too soon to determine whether the outbreak is ongoing, and contaminated products could still be served elsewhere. She added that cases not linked to Chipotle reported eating at a variety of other Mexican-style restaurants, indicating a broader impact across the foodservice industry.

The U.S. Food and Drug Administration (FDA) initiated a traceback investigation on July 22 after state officials and the Centers for Disease Control and Prevention (CDC) identified a cluster of Salmonella illnesses. The FDA is investigating multiple ingredients to determine the source and scope of contamination, though jalapeños remain the leading suspect. The agency’s investigation covers distribution beyond Minnesota, as the implicated jalapeño lot was supplied to several foodservice retailers across multiple states, according to FDA statements.

The outbreak timeline spans illnesses reported from mid-June through mid-July, with most linked to exposures in late June and early July. Chipotle’s removal of the jalapeños was publicly reported on August 4 in national media outlets. MDH officials indicated that other states are contributing to the investigation, suggesting the potential for wider distribution of contaminated jalapeños beyond Minnesota.

Officials from MDH and Chipotle have emphasized the company’s prompt response and ongoing cooperation. Medus praised Chipotle’s full collaboration, including providing detailed records of food deliveries and implementing mitigation measures. Schalow reiterated the chain’s commitment to food safety protocols and its proactive approach in removing the suspect jalapeños.

The current Salmonella Javiana outbreak is distinct from a separate cyclosporiasis outbreak affecting nine states, which involves a different pathogen. Media reports and public health sources have consistently noted that the salmonella cases are associated with Mexican-style quick-service restaurants broadly, not exclusively Chipotle.

Public health authorities continue to monitor the situation closely. MDH and the FDA have stressed that it is too early to declare the outbreak over and that investigations are ongoing to identify the exact source and distribution of the contaminated products. The FDA’s traceback efforts and collaboration with state and federal partners aim to prevent further illnesses and ensure food safety across affected regions.

Combined, these figures represent more than 11,000 reported illnesses this season, marking a record high for U.S. infections, according to CDC surveillance data and media reports from July 14. The agency noted that the current caseload includes both cluster-associated cases under Food and Drug Administration (FDA) traceback and sporadic cases without a known common source.

As of mid-July 2026, the Centers for Disease Control and Prevention (CDC) confirmed 4,173 laboratory‑confirmed, domestically acquired cases of cyclosporiasis across at least 34 states, with an additional 7,400 suspected illnesses under investigation, federal health officials said.

Among the outbreak investigations, a second cluster has been identified and linked to shredded iceberg lettuce served at Taco Bell restaurants in Indiana, Kentucky, Michigan, Ohio, and West Virginia. The CDC, FDA, and state health departments are actively investigating this multistate outbreak, which epidemiologic and traceback data indicate is connected to shredded iceberg lettuce from a single supplier in Mexico. Officials reported that 90% of interviewed patients in this cluster consumed iceberg lettuce in their meals. As of July 13, more than 400 Cyclospora infections in four states were linked to this source, with additional cases still under investigation. The CDC has advised consumers to avoid shredded iceberg lettuce from Mexico served at Taco Bell locations in the affected states while the FDA continues its traceback work.

Hospitalizations associated with cyclosporiasis have been reported but no deaths have occurred. Records show at least 308 hospitalizations linked to the current U.S. season, with some data sets indicating 141 hospitalizations among nearly 7,000 possible cases. Specifically, the Taco Bell outbreak has accounted for 94 hospitalizations among infected individuals who reported exposure at the chain’s locations in five states. Officials emphasized that, despite the “unusually high number” of cases, the illness is generally treatable with no fatalities confirmed to date.

The geographic spread of cases is broad, with reports placing confirmed infections in 34 to 41 states. CDC officials stressed that the current counts reflect a nationwide surveillance tally comprising multiple clusters and sporadic infections rather than a single unified outbreak. Michigan health authorities, for example, have interviewed more than 1,000 infected individuals, many of whom reported lettuce and salad greens as common exposures, though no specific brand or supplier has been definitively identified.

Cyclosporiasis is caused by the Cyclospora cayetanensis parasite, which is transmitted through food or water contaminated with fecal matter and is not typically spread from person to person, according to CDC information. Common symptoms include watery diarrhea, stomach cramps, nausea, loss of appetite, bloating, fatigue, and sometimes low-grade fever or flu-like symptoms. Without treatment, the illness can last from a few days to a month or longer and may be more severe in young children, older adults, and immunocompromised individuals. The CDC and other health authorities recommend specific antibiotics for treatment and stress the importance of adequate fluid intake to prevent dehydration. Officials also note that cooking is the only reliable method to kill the Cyclospora parasite on contaminated produce.

Public health guidance from the CDC includes washing hands with soap and water before and after handling produce, rinsing fruits and vegetables under clean running water, and scrubbing firm produce with a clean brush. Consumers are advised to buy whole heads of lettuce, remove outer leaves, thoroughly wash remaining leaves, and refrigerate cut or prepared produce within two hours. Amid ongoing investigations, the CDC cautioned against consuming shredded iceberg lettuce from Mexico served at Taco Bell locations in the five affected states.

The FDA’s traceback investigation is focused on the distribution pathways of shredded iceberg lettuce from Mexico to determine whether contaminated products may have reached locations beyond the initially identified states. Meanwhile, the broader multistate outbreak remains under investigation, with CDC officials stating on July 14 that no specific food source has yet been confirmed for cases outside the Taco Bell cluster. The agency continues to monitor the situation and update guidance as new information becomes available.

The recall includes both white shell eggs and brown cage-free shell eggs produced at two Midwest Poultry Services farms in Texas, officials said. The affected eggs were distributed under multiple major retail brands and private labels across at least six southern and southwestern states, including Texas, Louisiana, Oklahoma, Arkansas, and Mississippi, according to FDA reports and company notices. Retailers impacted by the recall include Kroger stores in Texas and Louisiana and Brookshire Grocery stores in Oklahoma, Arkansas, and Mississippi.

The recalled eggs bear “sell-by” or “best-by” dates ranging from July 20 through August 17, 2026, with plant codes P-1950 or 840962 printed on the side of the cartons, according to the FDA.

Consumers are advised to check for three-digit Julian dates from 157 through 184 alongside the plant codes; only eggs matching all three identifiers—plant code, Julian date, and sell-by/best-by date—are included in the recall, Midwest Poultry Services and FDA notices state. Eggs produced outside these date ranges or bearing different plant codes are not subject to the recall.

Midwest Poultry Services announced the voluntary recall through the U.S. Food and Drug Administration, emphasizing that no illnesses have been reported in connection with the recalled eggs. The company has halted distribution of eggs produced at its Texas farms while investigations and corrective actions are underway, FDA communications confirmed. The recall was initiated after environmental monitoring and root-cause analysis detected potential contamination with Salmonella Enteritidis at the production sites.

Salmonella Enteritidis is a strain commonly linked to egg-related foodborne illness outbreaks, the FDA said. According to the Centers for Disease Control and Prevention, Salmonella infection typically causes diarrhea, fever, and stomach cramps within six hours to six days after exposure, with illness lasting four to seven days. Severe cases can require hospitalization and pose increased risk to young children, older adults, and individuals with weakened immune systems.

The recall removes nearly 19 million individual eggs from the market, a preventive measure designed to reduce the risk of future illnesses. Midwest Poultry Services advised consumers not to consume the recalled eggs and to return them to the original place of purchase for a full refund. Public health officials recommend discarding any eggs that match the recall identifiers and sanitizing any surfaces or items that may have come into contact with the eggs using hot, soapy water or a dishwasher.

In recent years, health authorities have monitored a wave of egg recalls linked to Salmonella contamination, including a multistate outbreak associated with August Egg Company’s brown cage-free and organic eggs that resulted in 79 to 134 illnesses, 21 to 38 hospitalizations, and one death. The FDA continues to work with egg producers on corrective actions and preventive controls following contamination findings, including enhanced environmental sampling, process improvements, and hygiene measures.

Consumers experiencing severe symptoms such as persistent high fever, bloody diarrhea, or prolonged vomiting after consuming eggs are advised to seek medical attention, according to CDC guidance. Retailers and food service establishments are instructed not to sell or serve recalled eggs and to thoroughly clean and sanitize equipment and food-contact surfaces potentially exposed to the recalled products.

Midwest Poultry Services’ voluntary recall and distribution halt come as part of ongoing efforts to address potential contamination risks identified through environmental monitoring, officials said. The FDA and company representatives continue to investigate the source of contamination and implement measures to prevent future occurrences.

The travelers had returned to North America via Canada and were taken to the military base rather than entering the United States directly from Congo, officials said. U.S. health authorities coordinated the quarantine with the Department of Defense, which issued at least two internal notifications regarding the operation.

The group of 14 American citizens was quarantined for four days at a U.S. military base in New York State after returning from the Democratic Republic of Congo, where an Ebola outbreak is ongoing, according to Defense Department notifications reviewed by Reuters.

Officials emphasized that none of the travelers showed symptoms of Ebola, and they were assessed as not at risk of transmitting the virus at the time of quarantine, according to the Defense Department memo circulated to lawmakers. The memo stated there was “no danger to the public or base personnel,” framing the quarantine as a precautionary measure to contain any potential risk. Records and sources confirmed that none of the 14 developed symptoms during their four-day stay at the base.

The quarantine followed enhanced federal measures aimed at preventing the introduction of Ebola into the United States from affected regions. A “do-not-board” order issued in July requires U.S. citizens in Congo to quarantine for at least 21 days before they can return to the U.S. via commercial flights, according to multiple reports. However, current policies do not impose a blanket ban on returning citizens entering the U.S. through land crossings such as from Canada, which was the route taken by this group, sources said.

The Defense Department notifications made clear that the travelers could not return directly from Congo to the United States, reflecting tightened controls on direct inbound travel from Ebola-affected regions. These measures are part of the Trump administration’s efforts to “keep out individuals it deems at risk of Ebola,” even when those individuals are U.S. citizens, according to official communications reviewed by Reuters. The policies require medical clearance and completion of quarantine before travelers from Ebola zones are permitted to enter the country by commercial air.

The Democratic Republic of Congo has been experiencing an Ebola outbreak that has persisted over time, prompting heightened international monitoring and travel precautions, officials said. Public health experts note that Ebola has an incubation period of up to 21 days, which underpins the quarantine protocols and the 21-day requirement for travelers returning from affected areas. The U.S. quarantine of the 14 travelers was a preventive measure aligned with these incubation-period-based protocols, rather than a response to confirmed infection.

Legal and civil liberties concerns have been raised regarding the restrictions placed on American citizens returning from the Congo. Some legal analysts and public health experts have expressed unease about policies that appear to deny or delay entry to U.S. citizens, even when they are asymptomatic. Critics argue that such measures may conflict with constitutional protections and established norms regarding the right of citizens to re-enter their own country, according to legal commentaries published in recent months.

The current federal quarantine and travel restrictions draw on precedents set during the 2014 Ebola outbreak in West Africa. At that time, Connecticut’s governor authorized a mandatory 21-day quarantine for anyone with direct contact with Ebola patients, even if asymptomatic. Similarly, the governors of New York and New Jersey imposed mandatory 21-day quarantines on certain air travelers returning from West Africa who had contact with Ebola patients. New York later modified its policy to allow home quarantine with twice-daily health checks and some compensation for lost wages, reflecting efforts to balance public health control with civil liberties.

The quarantine of the 14 Americans at the New York military base fits into a broader trajectory of increasingly formalized Ebola travel screening and quarantine protocols in the United States since 2014. The Department of Defense and U.S. health officials continue to monitor travelers from Ebola-affected regions closely as part of ongoing efforts to prevent the virus from reaching American communities, according to officials involved in the operation.

The VOGUE trial, registered as NCT05979311, is a randomized, open-label Phase IIIb study designed to directly compare ViiV Healthcare’s two-drug regimen Dovato with Gilead Sciences’ three-drug regimen Biktarvy in treatment-naïve adults living with HIV-1, officials said. Conducted across 17 countries including Spain, Germany, Japan, and Argentina, the trial evaluates whether dropping a third antiretroviral drug can maintain virologic suppression as effectively as the standard three-drug therapy, even in individuals with high baseline viral loads, according to ViiV Healthcare. The study population consists of adults with no prior antiretroviral treatment history at baseline.

The trial aims to demonstrate whether the simpler two-drug regimen can provide non-inferior efficacy and an acceptable safety profile compared with the three-drug backbone that includes TAF, a widely used tenofovir prodrug.

Dovato combines dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg in a once-daily, single-tablet regimen, while Biktarvy includes bictegravir (BIC) plus emtricitabine (FTC) and tenofovir alafenamide (TAF) as a once-daily, single-tablet three-drug regimen. Both regimens are administered orally once daily, allowing a direct comparison in first-line HIV treatment, ViiV officials said.

ViiV Healthcare plans to present Week 48 data from VOGUE as an in-person poster at the 26th International AIDS Conference (AIDS 2026) scheduled for July 29, 2026, in Rio de Janeiro, according to conference records and Applied XL’s report on the study. The trial recently reached its revised enrollment target and moved to “Active, not recruiting” status after several extensions of its completion date, sources confirmed. ViiV’s July 2026 press materials highlight VOGUE among new data from its daily-oral portfolio, to be showcased alongside long-acting injectable innovations at major HIV scientific meetings, including AIDS 2026.

The VOGUE study builds on prior evidence supporting Dovato as a complete, once-daily, single-tablet regimen for adults with no antiretroviral treatment history and no known resistance to DTG or 3TC. The U.S. Food and Drug Administration approved Dovato based on pivotal GEMINI trials, which demonstrated non-inferior efficacy at Week 48 compared with a traditional three-drug regimen of dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). In GEMINI, virologic control was defined as HIV-1 RNA below 50 copies per milliliter, with no treatment-emergent resistance observed in either arm, according to FDA documents.

Further supporting the two-drug approach, ViiV’s TANGO study in virologically suppressed adults showed that switching to dolutegravir/lamivudine maintained non-inferior virologic efficacy versus a three-or-more-drug TAF-based regimen over three years, with no confirmed virologic withdrawals or resistance in the Dovato arm. At Week 96 in TANGO, 73% of participants on DTG/3TC had viral loads “target not detected,” compared with 69% on TAF-based regimens, ViiV officials said.

In February 2026, ViiV Healthcare announced 96-week data from the PASO DOBLE study (GeSIDA 11720), which analyzed virologically suppressed adults switching from Biktarvy to Dovato. Presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado, the data showed a statistically significant lower proportion of steatotic liver disease in the Dovato arm (29%) compared with Biktarvy (49%), with a p-value of 0.033. These findings contribute to the safety and metabolic profile discussion around TAF-based triple regimens versus DTG/3TC two-drug regimens, officials said.

ViiV Healthcare, majority owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, positions the VOGUE trial within its broader strategy to evaluate two-drug regimens as complete first-line treatments for HIV-1 infection in adults. The company emphasizes its “diverse portfolio and pipeline,” which includes daily-oral regimens such as Dovato and long-acting injectable treatments like Cabenuva, according to ViiV’s July 2026 press releases. Media contacts for ViiV include Kate Senter, Head of Global Communications, reachable at +44 7796 707446, and Rachel Jaikaran for U.S. media inquiries at +1 919 357 8932.

The VOGUE trial’s head-to-head comparison of Dovato and Biktarvy in treatment-naïve adults is expected to inform global first-line treatment discussions among clinicians and researchers. The upcoming data presentation at AIDS 2026 will add to the growing evidence base assessing the efficacy and safety of two-drug regimens against integrase inhibitor-based three-drug standards of care.

Officials said an additional 5,100 suspected cases are under review to determine whether they are domestically acquired, potentially raising the total number of cases to nearly 7,000. The CDC noted that 141 patients have been hospitalized, and no deaths have been reported in connection with the outbreak.

As of July 13, 2026, the Centers for Disease Control and Prevention reported 1,645 laboratory-confirmed cases of domestically acquired cyclosporiasis across 34 states, with illness onset dating back to May 1.

The agency emphasized that the outbreak is widespread and involves multiple multistate clusters. One notable cluster includes more than 400 cases spanning at least four Midwestern states: Michigan, Ohio, West Virginia, and Kentucky. Officials said these cases appear epidemiologically linked, suggesting a common source of infection, though no specific food or water vehicle has been confirmed. Michigan alone has reported nearly 1,000 cyclosporiasis cases in 2026, marking the largest outbreak in the state’s history and one of the largest in the United States in recent years, according to state health department records.

The CDC, Food and Drug Administration, and state and local health departments are coordinating investigations to identify the sources of infection. On July 14, the CDC issued a health advisory warning clinicians and the public about the increase in domestically acquired cyclosporiasis cases and the emerging multistate outbreak patterns. The advisory urged healthcare providers to consider cyclosporiasis in patients with prolonged or unexplained watery diarrhea and to order appropriate diagnostic testing, including stool examinations for the parasite *Cyclospora cayetanensis*. The CDC has activated its Emergency Operations Center to support the outbreak response, reflecting a coordinated national effort.

The median age of confirmed domestic case-patients is 44 years, with ages ranging from 2 to 95, and 56% of patients are female, according to CDC data. The median illness onset date among confirmed cases is June 22, with onset dates spanning from May 1 to July 9, indicating peak activity in late spring and early summer. In addition to domestically acquired cases, the CDC reported 440 cases classified as travel-associated, where illness developed after international travel within 14 days before onset.

Officials said the investigations have not yet identified a specific food item responsible for the outbreaks. While prior outbreaks in the United States have been linked to fresh produce such as salad mixes and cilantro imported from Mexico, the CDC and FDA stated that no particular product has been confirmed in the current events. Earlier this year, some illness clusters were associated with Mexican-style restaurants, a grocery chain, and a catered event, but these have not been publicly confirmed as sources for the national surge in cases.

Cyclosporiasis is an intestinal illness caused by the parasite *Cyclospora cayetanensis*, which is transmitted through ingestion of food or water contaminated with feces containing the parasite’s oocysts. Common symptoms include watery diarrhea, cramping, bloating, increased gas, nausea, fatigue, and weight loss. The illness can cause prolonged or relapsing diarrhea lasting weeks if untreated, but most otherwise healthy individuals recover with antibiotic treatment, typically trimethoprim-sulfamethoxazole. The parasite is generally not spread directly between people because the oocysts require time in the environment to become infectious. Vulnerable populations such as young children, older adults, and immunocompromised individuals may be at greater risk for dehydration and complications, which may explain the hospitalizations recorded in this outbreak.

Public health officials advise thorough washing of fresh produce under clean running water and adherence to food safety and hand hygiene practices to reduce the risk of infection. During the Michigan cluster, health authorities recommended consumers purchase whole heads of lettuce rather than prewashed, bagged salads, remove the outer two to three leaves, and wash the remaining leaves carefully. The CDC’s advisory also stressed the importance of reporting confirmed cases to state health departments to improve surveillance and outbreak investigations.

The CDC continues to work closely with the FDA and jurisdictional partners to analyze epidemiologic and genotyping data as investigations proceed. Officials noted that case counts are expected to rise as additional illnesses are confirmed and classified. The agency’s surveillance and outbreak pages will be updated with new information as it becomes available.

The approval expands Leqembi’s U.S. labeling to allow initiation of therapy using a subcutaneous injection as an alternative to the original biweekly intravenous (IV) starting regimen, according to the FDA and Eisai officials. The newly approved starting dose regimen for Leqembi Iqlik is 500 milligrams once weekly, delivered as two 250 mg subcutaneous injections administered in approximately 15 seconds each, records show. The subcutaneous autoinjector formulation is designed for at-home administration by patients or their care partners following appropriate training, Eisai representatives said.

In the Phase 3 CLARITY AD trial, lecanemab demonstrated a 27% reduction in clinical decline measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) over 18 months compared to placebo.

The FDA granted Priority Review to the supplemental Biologics License Application (sBLA) for the weekly starting dose, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026, before granting approval on July 13, 2026, according to agency records. This approval complements the prior FDA approval of Leqembi Iqlik 360 mg weekly subcutaneous maintenance dosing in August 2025, which allowed patients to continue therapy either by IV infusion every four weeks or weekly subcutaneous injections after an 18-month initiation period, Eisai and Biogen confirmed.

Clinical data supporting the approval include a comprehensive package evaluating subcutaneous administration of lecanemab across multiple studies and dosing regimens, officials said. The overall approval program is based on the Phase 3 CLARITY AD trial, in which lecanemab demonstrated a 27% reduction in clinical decline measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) over 18 months compared to placebo. A secondary endpoint, the Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), showed a 37% statistically significant benefit versus placebo, according to Eisai and Biogen.

Data presented by the companies indicate that transitioning to weekly Leqembi Iqlik after 18 months of IV initiation maintains clinical and biomarker benefits comparable to continued IV dosing. The FDA had previously converted Leqembi’s accelerated approval to traditional approval after confirmation of clinical benefit, establishing the drug’s efficacy for Alzheimer’s disease treatment, agency sources said.

The safety profile of the subcutaneous formulation is similar to intravenous infusion, with no new major safety signals identified, Eisai reported. Injection-related reactions are primarily localized and include erythema, induration, swelling, heat, pain, pruritus, rash, ecchymosis, nodules, and hematoma, most commonly occurring at the first dose. Less frequent systemic reactions such as headache, chills, fever, and fatigue are generally mild to moderate. Prescribers are advised to monitor for recurrent or delayed localized reactions during ongoing weekly administration. Both IV and subcutaneous regimens retain class-typical risks related to amyloid-related imaging abnormalities (ARIA), with specific ARIA data for the subcutaneous starter dose encompassed within the broader clinical safety package referenced in the approval.

Leqembi is indicated in the United States for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease, collectively referred to as early Alzheimer’s disease in company communications and labeling. Eisai and Biogen emphasized that the drug is intended for adult patients only, with no pediatric use included in the indication or clinical development. The Alzheimer’s Association, based in Chicago, welcomed the FDA’s approval on July 13, 2026, noting that Leqembi Iqlik is the first monoclonal antibody that clears amyloid beta for early Alzheimer’s disease to be approved for subcutaneous administration using an autoinjector, a status now encompassing both maintenance and starter dosing.

Eisai’s partner BioArctic reported that the company plans to launch the Leqembi Iqlik starting dose in the U.S. in late August 2026, following the FDA approval. The maintenance-dose formulation was launched on October 6, 2025, after the August 29, 2025 FDA approval, according to Eisai. Company communications stress that the subcutaneous autoinjector option may increase convenience and flexibility for patients and care partners by providing an at-home weekly injection alternative to infusion-center IV therapy, potentially reducing logistical burdens associated with regular IV infusions.

With the new starting-dose approval, Leqembi now supports a fully integrated IV and subcutaneous treatment pathway, enabling initiation and continuation of therapy either by infusion or autoinjector, with the option to switch between routes over time. This integrated approach aims to provide patients with early Alzheimer’s disease greater flexibility in managing their treatment regimen.

The infections are concentrated primarily in southeast Michigan counties including Wayne, Oakland, Washtenaw, Monroe, Lenawee, Shiawassee, Jackson, Ingham, and Livingston, according to state updates and local health reports. The department described the situation as a growing outbreak and emphasized that investigations are ongoing.

The Michigan Department of Health and Human Services (MDHHS) reported a rapid increase in cyclosporiasis cases, rising from 1,562 on July 10 to 2,640 by July 13, 2026, indicating a significant escalation in the outbreak over a short period.

Preliminary testing by MDHHS has identified lettuce and salad greens as a potential source of the outbreak, though officials have not yet confirmed any specific grower, supplier, or produce type linked to the cases. Dr. Natasha Bagdasarian, Michigan’s chief medical executive, stated that while no definite product has been identified, early information shows lettuce as a common item associated with the investigation. MDHHS also noted that other food items have not been ruled out and that the findings remain preliminary.

The department issued public guidance on July 4, 2026, to help prevent foodborne illness amid the outbreak. This included recommendations to buy whole heads of lettuce rather than prewashed bagged lettuce or salad mixes, discard the outer two to three layers of leaves, and wash inner leaves under running water. For leafy greens that can be cooked, MDHHS advised that cooking is the safest option, as heating food to 158 degrees Fahrenheit (70 degrees Celsius) or higher kills Cyclospora parasites. Consumers were also urged to wash all fresh produce thoroughly, even if it will be peeled later.

Cyclospora infection typically causes watery or severe diarrhea, stomach cramps, and nausea, according to local health reports linked to the outbreak. Treatment involves antibiotics, along with rest and adequate hydration, officials said. MDHHS urged those experiencing symptoms to contact their health care provider and local health department. The department also recommended handwashing with soap and water before and after handling food and sanitizing utensils, cutting boards, refrigerators, and produce display cases to reduce the risk of contamination.

The outbreak timeline shows a sharp increase in cases over recent weeks. On June 30, 2026, local reports indicated 572 cases, up from 170 earlier that week. By July 4, MDHHS had issued its initial public recommendations, and on July 5, the department confirmed that no specific grower or supplier had been identified. State bulletins on July 7 reported 784 cases clustered in multiple southeast Michigan counties, with numbers continuing to climb sharply through mid-July.

MDHHS highlighted that several foods have been linked to previous Cyclospora outbreaks in the U.S. and Canada, including bagged salad mixes and kits, fresh cilantro, fresh basil, raspberries, snow peas, and green onions. The department’s guidance specifically noted bagged salad mixes and kits as pre-cut lettuce blends associated with earlier outbreaks and identified lettuce and leafy greens as foods requiring special caution during the current investigation.

The department maintained an active investigation status as of the latest updates, with source identification still incomplete. Officials continue to monitor the outbreak and update the public through the MDHHS Cyclosporiasis Outbreak 2026 webpage. The department’s ongoing efforts include testing potential sources and coordinating with local health agencies to track new cases and provide updated guidance.