Pirtobrutinib, marketed as Jaypirca by Eli Lilly and Company, is approved for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a deletion of chromosome 17p, according to the FDA’s announcement on October 2, 2026. This approval marks the first time pirtobrutinib has been authorized for use in the frontline treatment setting for these patients, expanding its indication beyond relapsed or previously treated B-cell malignancies, Eli Lilly officials said.

The trial compared pirtobrutinib monotherapy with the chemoimmunotherapy regimen bendamustine plus rituximab.

The FDA’s decision was based on data from the phase 3 BRUIN CLL-313 trial (ClinicalTrials.gov identifier NCT05023980), a randomized study that enrolled 282 adults with previously untreated CLL or SLL lacking the high-risk del(17p) genetic abnormality. Results demonstrated a statistically significant improvement in progression-free survival for patients receiving pirtobrutinib, according to the FDA’s approval documents and trial reports.

Patients in the study received pirtobrutinib at a dose of 200 mg orally once daily until disease progression or unacceptable toxicity, sources confirmed. Jaypirca is available in 50-mg and 100-mg tablet formulations, facilitating oral administration rather than intravenous infusion. The FDA’s approval specifically excludes patients with known deletion of chromosome 17p, a genetic marker associated with higher-risk disease, reflecting the trial’s enrollment criteria and the population for which the drug’s efficacy and safety were established.

Eli Lilly described pirtobrutinib as a noncovalent Bruton tyrosine kinase (BTK) inhibitor, distinguishing it from covalent BTK inhibitors currently used in CLL and SLL treatment. This reversible binding mechanism is noted as a novel approach in targeting BTK, the enzyme involved in B-cell receptor signaling that contributes to malignant B-cell proliferation. The FDA’s action represents the first approval of a noncovalent BTK inhibitor for initial treatment of CLL and SLL, company representatives said.

The BRUIN CLL-313 trial enrolled adults who were initiating systemic therapy for CLL or SLL and had no known del(17p), a subgroup that excludes patients with this high-risk chromosomal deletion. The study’s primary endpoint was progression-free survival, and the trial met this endpoint with a statistically significant benefit for pirtobrutinib compared to bendamustine plus rituximab, according to published trial data and FDA briefing materials. The safety profile observed in the trial supported continued treatment until progression or toxicity, officials noted.

Chronic lymphocytic leukemia is a malignancy of mature B lymphocytes circulating in the blood, while small lymphocytic lymphoma represents the same disease process primarily involving lymph nodes or other tissues. The deletion of chromosome 17p is a well-recognized adverse prognostic marker in both CLL and SLL, often guiding treatment decisions. The FDA’s approval restricts the new indication to patients without this deletion, consistent with the clinical trial population and evidence base.

The FDA and Eli Lilly simultaneously announced the expanded indication on October 2, 2026. This approval provides an additional oral treatment option for adults with untreated CLL or SLL lacking del(17p), broadening the therapeutic landscape beyond existing chemoimmunotherapy and covalent BTK inhibitor regimens. The FDA’s prescribing information specifies that pirtobrutinib should be administered as monotherapy at 200 mg daily and continued until disease progression or unacceptable adverse effects occur.

Pirtobrutinib’s prior FDA approvals covered its use in certain relapsed or refractory B-cell malignancies, but this new indication marks its entry into the frontline treatment setting. The decision is based on robust phase 3 evidence from the BRUIN CLL-313 trial, which enrolled 282 patients and demonstrated a clear progression-free survival advantage over bendamustine plus rituximab, a standard chemoimmunotherapy regimen. The trial’s results and FDA approval documents emphasize the importance of genetic testing for del(17p) to determine patient eligibility for pirtobrutinib in this setting.

The approval adds to the evolving treatment options for CLL and SLL, diseases characterized by abnormal B-cell proliferation and often requiring systemic therapy when symptomatic or progressive. The restriction to patients without del(17p) aligns with current clinical practice of stratifying treatment based on genetic risk factors. Further research and postmarketing data will continue to inform the role of pirtobrutinib and other BTK inhibitors in managing these hematologic malignancies.

The program supports treatment and recovery for individuals affected by opioid addiction and seeks to reduce illicit opioid use and prescription-opioid misuse, according to the Department of Health and Human Services. Overdose reduction is a central goal of this investment, HHS added.

The largest portion of the funding, $69.4 million, was awarded to the Medication-Assisted Treatment—Prescription Drug and Opioid Addiction program, which aims to expand access to medications for opioid use disorder, officials said.

Project AWARE received $54.9 million to help local and tribal education agencies strengthen mental health services for school-aged children and adolescents, according to SAMHSA records. The program supports activities addressing mental illness, substance use, and co-occurring disorders among youth. It also promotes social and emotional well-being, officials said, placing schools and education agencies among the primary settings for expanded youth behavioral-health services.

Another significant allocation of $41.8 million went to the National Child Traumatic Stress Initiative—Category III Community Treatment and Service Centers. These grants will establish and operate community treatment and service centers to expand access to trauma treatment for children, youth, and families affected by traumatic events, according to HHS. The program connects trauma-focused care with broader community-based mental health support, officials said.

The First Responders—Comprehensive Addiction and Recovery Act program was awarded $34.6 million to support first responders and communities working to reverse overdoses, sources confirmed. This funding complements addiction-treatment grants by addressing overdose emergencies in community settings. HHS’s announcement linked overdose prevention with treatment access and recovery support, underscoring the role of first responders in the broader effort to combat substance use disorders.

Recovery support and workforce-related services are also included in the funding package, officials said. The grants aim to help people access treatment and continue recovery after receiving care, with SAMHSA’s investments addressing both mental health conditions and substance-use disorders. Supported services include community-based treatment, prevention, and recovery activities, as well as assistance to help people in recovery return to work, according to the American Hospital Association.

Together, the four largest programs—opioid-treatment grants, Project AWARE, trauma-treatment centers, and first-responder grants—account for $200.7 million of the $247.9 million total, records show. More than $96 million was directed specifically to children’s mental health and trauma services through Project AWARE and the National Child Traumatic Stress Initiative, according to HHS.

The grants cover a broad range of behavioral-health interventions, including treatment, overdose prevention, mental health services, and recovery support, rather than focusing on a single approach, officials said. The initiative represents an investment in communities across the United States, according to HHS.

The Substance Abuse and Mental Health Services Administration, the HHS agency administering the grants, announced the awards on September 25, 2026. The funding is part of a continuing effort to address the nation’s behavioral health challenges by expanding access to effective treatment and support services.

Médecins Sans Frontières (MSF) confirmed on October 1, 2026, that one of its staff members working on the Ebola response in the Democratic Republic of Congo (DRC) tested positive for Bundibugyo virus disease, a form of Ebola caused by the Bundibugyo virus, according to the organization’s statement and contemporaneous reporting. The infected worker, identified by Dutch authorities as an MSF doctor, was evacuated from the DRC under strict medical protocols coordinated between health authorities in both countries, Reuters reported. The patient was transferred to a specialized isolation unit at Leiden University Medical Center, located approximately 40 kilometers southwest of Amsterdam, for treatment.

The Bundibugyo virus, first identified in Uganda’s Bundibugyo district, is a distinct strain of Ebola virus disease from the more commonly reported Zaire ebolavirus.

MSF withheld personal details of the staff member, including name, nationality, sex, and specific work location, citing medical confidentiality and privacy concerns, the organization said. The group confirmed the case involved a humanitarian worker deployed as part of the international response to the ongoing Ebola outbreak in the DRC. Dutch health officials described the patient as a doctor assisting in efforts to combat the outbreak, according to Reuters.

MSF and news reports referred to the infection as Ebola disease caused by Bundibugyo virus, but neither MSF nor other sources disclosed details about the worker’s symptoms, clinical condition, or prognosis. The organization also did not specify how or when the worker contracted the virus.

The infected MSF staff member’s case emerged amid what has been described as the largest Ebola outbreak ever recorded in the DRC. Reports indicate approximately 8,000 confirmed cases and around 4,000 deaths, although these figures remain subject to revision as suspected cases undergo investigation and records are updated. The outbreak has prompted a broad international response involving national health authorities, the World Health Organization (WHO), MSF, and other humanitarian and medical organizations.

Health workers have been significantly affected during the outbreak. WHO reported 151 confirmed infections among health workers, including 44 deaths and 68 recoveries, as of its August 2026 disease outbreak report. The organization calculated a 29% case-fatality ratio among infected health workers. These infections highlight the occupational risks faced by medical personnel, who may be exposed through direct patient care, handling infectious materials, or breaches in infection-prevention protocols. WHO’s figures encompass health-worker infections across the outbreak and do not specifically pertain to MSF personnel alone.

The evacuation of the infected MSF worker was carried out under strict medical protocols designed to prevent onward transmission and ensure specialized care. MSF coordinated the transfer with health authorities in both the DRC and the Netherlands, the organization said. Dutch health ministry officials confirmed the patient’s admission to a high-level isolation unit at Leiden University Medical Center, a facility equipped to provide specialized treatment while minimizing the risk of further infections, Reuters reported. There have been no official reports of secondary infections linked to the evacuated MSF worker.

MSF’s initial public statement on October 1 confirmed the positive test and the medical evacuation but intentionally omitted identifying and clinical details to protect the staff member’s privacy. Reuters reported on the same day that the worker was being evacuated to the Netherlands, and by October 2, sources confirmed the patient had arrived and been admitted to the isolation unit at Leiden University Medical Center. WHO had previously reported humanitarian workers contracting Bundibugyo virus in the DRC and being medically evacuated to Europe earlier in 2026.

As of the latest reporting, no official sources have disclosed the current condition or outcome of the infected MSF worker. The ongoing outbreak continues to be monitored by international health authorities, with efforts focused on containment, treatment, and protecting frontline medical personnel.

This marks an expansion from earlier Emergency Use Authorizations (EUAs) that permitted these drugs solely for treatment of New World screwworm (NWS) infestations, caused by *Cochliomyia hominivorax* larvae, to now include prevention in companion animals nationwide. The FDA’s action is part of the federal government’s response to a potential public health emergency posed by the invasive parasite, officials said.

The authorization covers Capstar (nitenpyram) tablets and generic Nitenpyram tablets for use in dogs, puppies, cats, and kittens weighing at least 2 pounds and at least 4 weeks old, according to FDA documents dated September 3, 2026.

The FDA issued the original EUA for generic Nitenpyram tablets on June 11, 2026, authorizing their use for treatment of NWS in dogs and cats. The September 3 revision aligns the generic product’s indication with Capstar’s, which received its first EUA for both prevention and treatment on the same day. Both authorizations were granted under section 564 of the Federal Food, Drug, and Cosmetic Act, the same legal authority used for human medical countermeasures, FDA records show. The agency concluded that the benefits of emergency use outweigh known and potential risks in the context of the NWS public health emergency, according to the EUA letters to manufacturers.

Earlier in 2026, the FDA authorized other drugs for treatment of NWS infestations in dogs and cats. On February 18, the agency issued EUAs for NexGard (afoxolaner) chewable tablets for dogs and NexGard COMBO (esafoxolaner, eprinomectin, and praziquantel topical solution) for cats, both limited to treatment, not prevention, of screwworm myiasis. Boehringer Ingelheim, the manufacturer, confirmed these authorizations in a corporate release dated February 19, 2026, emphasizing support for veterinarians and pet owners managing NWS cases. Additionally, Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) received an EUA on August 13, 2026, for treatment of NWS infestations in dogs and puppies only, with no preventive indication. USDA’s Animal and Plant Health Inspection Service (APHIS) also announced this authorization on the same date.

According to FDA’s “Animal Drugs for New World Screwworm” webpage, as of September 3, 2026, the agency has issued 15 EUAs and three conditional approvals for animal drugs targeting NWS across multiple species, including companion animals, livestock, birds, and exotic mammals. These regulatory actions are contingent on a declaration by the Department of Health and Human Services that the potential public health emergency posed by NWS justifies emergency use authorizations for animal drugs. FDA and USDA APHIS coordinate communications to veterinarians and industry stakeholders, directing them to official FDA pages listing authorized drugs and relevant documentation such as letters of authorization, fact sheets, and environmental assessments.

The scope of the EUAs varies by product and species. Capstar and generic Nitenpyram tablets are authorized for both prevention and treatment in dogs, puppies, cats, and kittens meeting weight and age criteria. NexGard and NexGard COMBO EUAs remain limited to treatment in dogs and cats, respectively, without preventive use. Simparica TRIO’s EUA covers treatment only in dogs and puppies. The FDA has also authorized F10 Antiseptic Wound Spray with Insecticide for prevention and treatment of NWS in multiple species but explicitly prohibits its use in domestic dogs and cats. Federal communications emphasize that use outside the authorized species or indications is not permitted under the emergency provisions.

The FDA advises veterinarians to consult detailed fact sheets and letters of authorization for guidance on dosage, safety, and administration of these drugs under the EUAs. The agency’s September 3 announcement highlighted the shift toward prophylactic management of at-risk dogs and cats in areas affected or threatened by NWS. The invasive screwworm larvae cause myiasis, a condition that can be fatal if untreated, prompting the federal emergency declarations and regulatory responses.

The EUAs remain effective until revoked by the FDA or until the Secretary of Health and Human Services terminates the underlying emergency declaration related to NWS. The ongoing federal response reflects efforts to control and prevent spread of the parasite in the United States, involving multiple authorized drugs and coordinated veterinary guidance.

The FDA approved Zanvastro nearly three weeks ahead of the scheduled September 22, 2026, target action date, granting the drug Priority Review status, according to the agency’s announcement. Zanvastro (zilganersen), developed by Ionis Pharmaceuticals, is the first FDA-approved treatment for Alexander disease, an ultra-rare neurodegenerative disorder that affects both pediatric and adult patients. Ionis officials confirmed the approval in a September 3 press release, describing Zanvastro as the “first and only disease-modifying treatment” for Alexander disease.

Clinical trial data cited by Ionis and independent analyses showed that patients treated with Zanvastro experienced stabilization of walking speed, while untreated patients exhibited a 33% decline in gait speed, a key endpoint for neurological disorders.

Zanvastro is an RNA-targeted antisense therapy designed to reduce the abnormal buildup of glial fibrillary acidic protein (GFAP) in astrocytes, a hallmark of Alexander disease pathology. The drug is administered by intrathecal injection into the cerebrospinal fluid, typically on a quarterly schedule, according to clinical trial reports and company materials. While not a cure, the therapy aims to slow or stabilize disease progression, particularly motor and functional decline, officials said.

In children aged 2 to 4, treated patients demonstrated motor improvements, with those aged 5 and older showing stabilization of gait speed, sources confirmed. These results represent the first evidence of disease-modifying impact in Alexander disease and were pivotal to the FDA’s approval decision.

The FDA approval covers both pediatric and adult patients, providing the first authorized therapy for children with Alexander disease, which is often diagnosed in early childhood. Advocacy groups noted that prior to Zanvastro, treatment options were limited to symptomatic management, such as seizure control and spasticity relief. The broad label encompassing all ages was highlighted by external experts as significant given the disease’s early onset and progressive nature.

Alexander disease is an ultra-rare leukodystrophy caused by pathogenic variants in the GFAP gene, leading to toxic protein accumulation and widespread central nervous system dysfunction. The disorder affects motor, cognitive, autonomic, and gastrointestinal functions and has historically been fatal without approved treatments. Records from the FDA’s rare disease approvals list include Zanvastro under the 2026 rare disease drug approvals, confirming its status as the first drug approved for this condition.

Ionis Pharmaceuticals announced that Zanvastro would be available to U.S. patients “in the coming weeks” following the approval. The company set the price at $285,000 per dose, consistent with costs typical of ultra-rare disease therapies, Reuters reported. Ionis also launched a patient support program called Ionis Every Step to assist families with education, insurance navigation, and affordability resources as the drug becomes commercially available.

The FDA granted Ionis a Rare Pediatric Disease Priority Review Voucher in conjunction with the approval, a regulatory incentive aimed at encouraging development of therapies for rare pediatric conditions. Ionis retains U.S. commercialization rights, while Recordati holds rights outside the United States, according to industry sources.

FDA officials emphasized that Zanvastro is the first therapy to directly target the protein buildup that drives Alexander disease, marking a scientific advance for this pediatric and adult indication. Ionis’ CEO described the drug as establishing a new pillar in the company’s rare disease pipeline. Rare disease advocacy organizations characterized the approval as a historic milestone for families affected by Alexander disease, enabling access to the first disease-modifying therapy despite the drug not being curative.

Alexander disease was first genetically characterized nearly 30 years ago, but until Zanvastro’s approval, no FDA-approved treatments existed. Care had been limited to managing symptoms such as seizures, spasticity, and feeding difficulties. The approval represents a significant development for a disorder that has been historically neglected in pediatric neurodegenerative research and drug development.

The five Listeria monocytogenes infections linked to the outbreak were confirmed through laboratory testing and occurred across multiple states, with all patients requiring hospitalization, according to the Centers for Disease Control and Prevention. Epidemiologic investigations identified three varieties of Crave Brothers soft-ripened cheeses—Les Frères, Petit Frère, and Petit Frère with truffles—as the common food exposure among all patients, officials said. Patients reported consuming these cheeses at both restaurants and retail grocery stores, indicating multiple points of sale rather than a single distribution source.

According to CDC records, hospitalization rates in soft-cheese-related Listeria outbreaks often exceed 80 to 90 percent of reported cases.

Following the identification of Crave Brothers cheeses as the likely source, public health authorities initiated a nationwide recall of the implicated products to prevent further illnesses. The recall was part of a coordinated response involving the CDC, state health departments, and the Food and Drug Administration. The CDC issued food safety alerts advising consumers, particularly those at higher risk for severe listeriosis—including pregnant women, older adults, newborns, and people with weakened immune systems—to avoid consuming the recalled cheeses and to discard or return any remaining products.

Listeriosis, caused by Listeria monocytogenes, is a serious infection known for high hospitalization rates and potential fatality, especially among vulnerable populations. Previous outbreaks linked to soft cheeses have resulted in double-digit case counts and deaths, underscoring the severity of such contamination events.

Soft-ripened cheeses have been repeatedly implicated in multistate Listeria outbreaks. In addition to the 2013 Crave Brothers outbreak, other investigations have linked soft and fresh cheeses sold under various retail brands, including Whole Foods Market’s 365 brand, to Listeria infections. For example, a 2024 multistate outbreak associated with Rizo-López Foods involved more than 60 recalled dairy products such as queso fresco, Cotija cheese, yogurt, and sour cream sold under multiple brand names, including 365 Whole Foods Market. That outbreak resulted in 26 illnesses, 23 hospitalizations, and two deaths across 11 states, according to CDC and FDA reports.

Whole Foods Market has also voluntarily recalled soft wash-rind raw milk cheeses from Vulto Creamery—specifically the Ouleout and Miranda varieties—from nine stores in Connecticut, Massachusetts, Maine, and New York. The recall followed findings of Listeria contamination in FDA testing, which detected Listeria monocytogenes in Ouleout lot #617 and possible contamination in lot #623, as reported by the New York State Department of Agriculture and Markets. These cheeses were cut and repackaged in clear plastic wrap and labeled with PLU codes 0200305 and 0200306, with “sell by” dates ranging from December 27, 2016, to March 28, 2017.

The CDC and regulatory agencies use epidemiologic interviews and laboratory analyses, including whole genome sequencing, to link Listeria infections to specific products and brands. In the 2013 outbreak, all five patients reported consuming Crave Brothers cheeses, which guided investigators to identify and recall the contaminated products. Similar investigative approaches have been employed in other outbreaks, such as a 2023 multistate cluster linked to Clover Hill Dairy’s requesón cheese, which resulted in 15 confirmed infections across four states.

The recurring pattern of multistate Listeria outbreaks linked to soft cheeses highlights the ongoing risk associated with these products. Scientific studies and outbreak investigations have shown that soft cheeses, including those made from pasteurized milk, remain vulnerable to contamination due to post-pasteurization exposure and the ability of Listeria to grow in refrigerated environments. Health authorities continue to monitor and respond to such outbreaks, issuing recalls and public warnings to protect consumers.

The CDC and FDA maintain active surveillance and coordination with state agencies to identify additional cases and contaminated products. Public health officials emphasize that high-risk groups should exercise caution with all soft cheeses, especially during outbreaks, and adhere to recall notices to reduce the risk of listeriosis.

Lisraya (brepocitinib) is the first oral drug approved by the U.S. Food and Drug Administration specifically for the treatment of dermatomyositis in adults, Roivant Therapeutics and its affiliate Priovant Therapeutics announced following the August 27, 2026, approval. The FDA described Lisraya as a first-in-class dual TYK2/JAK1 inhibitor, offering a targeted immunomodulatory therapy for this rare autoimmune disease. Roivant confirmed that the 30 mg once-daily oral tablet is approved for use in the United States immediately, with no restrictions based on disease activity, clinical presentation, or prior treatment experience.

In the 52-week randomized, placebo-controlled trial, adults with dermatomyositis receiving brepocitinib 30 mg daily achieved a mean myositis Total Improvement Score (TIS) of 46.5 compared to 31.2 in the placebo group, a statistically significant difference.

The approval was based primarily on data from the Phase 3 VALOR trial, which is the largest clinical study conducted to date in dermatomyositis patients, according to Priovant. The TIS is a composite measure that evaluates multiple disease domains, including muscle strength, patient and physician global assessments, and skin involvement, officials said. Clinical benefit was evident as early as Week 4 and sustained through Week 52, demonstrating durable efficacy across the disease spectrum.

The VALOR study also highlighted Lisraya’s steroid-sparing effects. Among patients who were on oral corticosteroids at baseline, 62% of those treated with brepocitinib tapered to minimal or no steroid use by Week 52, compared with 38% in the placebo group. Furthermore, 45% of brepocitinib-treated patients fully discontinued corticosteroids by the end of the study versus 29% of placebo patients, according to trial data published in the New England Journal of Medicine and detailed by Priovant. These results underscore the potential for Lisraya to reduce reliance on chronic corticosteroid therapy, which is commonly used but associated with significant side effects.

Dermatomyositis is a rare systemic autoimmune disease characterized by chronic inflammation, progressive muscle weakness, and distinctive skin rashes. It affects an estimated 50,000 Americans, according to coverage of the VALOR trial results. Prior to Lisraya’s approval, treatment options consisted mainly of broad immunosuppressive regimens, including corticosteroids and other systemic agents, with no targeted oral therapies specifically approved for this condition. The Muscular Dystrophy Association welcomed the approval as a milestone, noting it is the first targeted therapy approved specifically for adults with dermatomyositis.

Brepocitinib was developed and is marketed by Priovant Therapeutics, a Roivant-affiliated company focused on autoimmune diseases. Roivant and Priovant announced positive Phase 3 VALOR results on September 17, 2025, and filed a New Drug Application (NDA) with the FDA in the first half of 2026. The FDA accepted the NDA and granted Priority Review, with the Prescription Drug User Fee Act (PDUFA) target action date set for the third quarter of 2026. Following approval, Roivant stated that commercial and manufacturing preparations would scale up immediately, with Lisraya now available for prescription in the U.S. through the company’s enrollment and distribution channels.

Lisraya’s mechanism of action targets the TYK2 and JAK1 signaling pathways implicated in the pathogenesis of dermatomyositis, introducing a novel approach compared with traditional broad immunosuppressants such as corticosteroids and conventional disease-modifying antirheumatic drugs (DMARDs), according to Roivant and regulatory documents. The absence of restrictions in the FDA label suggests broad real-world applicability for adult patients with varying disease severities and clinical presentations.

Analysts and advocacy groups anticipate that Lisraya’s approval will influence future treatment guidelines and standards of care for dermatomyositis. The drug’s designation as the first oral and first targeted therapy for this rare condition marks a significant regulatory and therapeutic development. Roivant and Priovant continue to monitor post-approval outcomes and plan further studies to explore Lisraya’s long-term safety and efficacy profiles.

The presence of these undeclared pharmaceutical ingredients rendered the product an unapproved drug, prompting the agency to classify the recall as a safety action due to the significant health risks posed to consumers, particularly those with underlying medical conditions or who are taking other medications that may interact adversely, officials said. The FDA’s Human Foods Program issued a public warning on July 17, 2024, advising consumers to stop using Infla-650 capsules immediately.

The recalled Infla-650 capsules were found to contain acetaminophen, diclofenac, and phenylbutazone, none of which were declared on the product label, according to FDA testing results released July 16, 2024.

The FDA’s action against Infla-650 is part of a broader, multi-year enforcement effort targeting dietary and herbal supplements adulterated with prescription drugs or other hidden ingredients, records show. The agency maintains a Health Fraud Product Database that catalogs products found to contain undeclared pharmaceuticals, along with recall statuses and enforcement actions. This database includes numerous supplements marketed for pain relief, sexual enhancement, weight loss, and bodybuilding that have tested positive for hidden drugs, according to FDA notifications and health-fraud bulletins.

Other recent FDA investigations have uncovered undeclared nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam in herbal joint-pain supplements, as well as weight-loss products containing tianeptine, 1,4-DMAA, and aniracetam—ingredients not approved for dietary use due to cardiovascular and neurological risks, sources confirmed. Additionally, herbal powders and capsules from HerbsForever LLC, including Hingwastik Churna powder and Gastro Care capsules, were voluntarily recalled after FDA inspectors detected undeclared wheat, a known allergen that can trigger severe reactions in sensitive individuals.

The sexual-enhancement and energy supplement category has frequently been implicated in FDA recalls involving hidden drugs such as sildenafil, tadalafil, sulfoaildenafil, hydroxythiohomosildenafil, and related analogues. These substances are prescription-only erectile dysfunction drugs that pose dose-related risks, especially when consumers are unaware of their presence. In April 2017, Organic Herbal Supply Inc. voluntarily recalled multiple herbal male-enhancement products, including Uproar, Cummor, Zrect, Monkey Business, and others, after FDA analysis revealed undeclared tadalafil, sildenafil, and their analogues. The company also recalled Zrect for Women and LabidaMAX capsules following the detection of flibanserin, a prescription drug approved for hypoactive sexual desire disorder in women, officials said.

Health risks associated with these hidden ingredients are well-documented. Acetaminophen, when consumed unknowingly in combination with other acetaminophen-containing medications, can cause liver damage. Undeclared diclofenac and phenylbutazone increase the risk of gastrointestinal bleeding, kidney injury, cardiovascular events, and blood disorders, especially among people with arthritis, heart disease, or those on interacting therapies, according to FDA safety communications. Similarly, hidden meloxicam and other NSAIDs can lead to ulcers, bleeding, and renal impairment. Stimulant-like substances such as 1,4-DMAA and nootropics like aniracetam found in some herbal weight-loss supplements have been linked to severe cardiovascular and neurological events.

FDA public notifications emphasize that products containing undeclared pharmaceutical ingredients are unapproved drugs without established safety or efficacy for over-the-counter use. The agency advises consumers to discontinue use of recalled products and consult healthcare professionals if they experience adverse effects such as chest pain, shortness of breath, severe headaches, allergic reactions, or gastrointestinal bleeding. Healthcare providers and consumers are encouraged to report adverse events to support ongoing investigations and potential recalls.

FDA enforcement measures include voluntary recalls initiated by companies in coordination with the agency, as well as import alerts, warning letters, and other actions against firms that do not cooperate or have repeated violations. A study analyzing FDA data from 2007 to 2016 found that unapproved pharmaceutical ingredients were repeatedly detected in dietary supplements, particularly in sexual enhancement, weight-loss, and bodybuilding products. The most frequently found hidden drugs included sibutramine, sulfoaildenafil, sildenafil, tadalafil, hydroxythiohomosildenafil, and dimethylsildenafil.

The agency’s Health Fraud Product Database and category-specific notification pages provide consolidated lists of tainted supplements, including those marketed for pain, arthritis, sleep, skin, bodybuilding, and sexual enhancement. These resources aim to inform consumers and healthcare professionals about the risks posed by fraudulent products that circumvent drug-approval requirements. Recalls such as the one involving Infla-650 capsules illustrate the FDA’s ongoing efforts to protect public health from adulterated herbal supplements containing undisclosed pharmaceutical ingredients.

Secretary of Health Dr. Debra Bogen issued the official announcement, describing the fatalities as measles-associated without releasing further clinical details or identifying information to protect privacy. A subsequent national report indicated one of the deceased was an infant, though this was not included in the initial state statement. The department emphasized that these are the first measles-related deaths in Pennsylvania in 35 years.

The Pennsylvania Department of Health confirmed the deaths on August 25, 2026, identifying both individuals as unvaccinated residents of Lancaster County.

The announcement occurred amid a widespread measles outbreak in Pennsylvania that has affected 393 people across 29 counties in 2026, according to state records as of August 25. The Department of Health’s measles information page now lists the deaths as a major update in the ongoing outbreak response. Earlier in the year, the state reported 84 confirmed cases by late June, with the outbreak initially identified in Lebanon County in late April. By that time, 72 cases were linked to the Lancaster-Lebanon region alone.

The outbreak has since expanded beyond central Pennsylvania, with cases reported in Berks, Dauphin, Lancaster, Lebanon, Northumberland, and York counties. Lancaster County has remained the most heavily affected area, including as the location of the two deaths, according to state officials. Early investigations suggested the spread was community-associated rather than connected to domestic or international travel.

State health officials stressed the role of non-immunization in the severity of the outbreak. Both deceased individuals were unvaccinated, underscoring the Department of Health’s ongoing efforts to promote the measles, mumps, and rubella (MMR) vaccine. The department noted that while measles deaths are rare, the disease can be fatal, citing a fatality rate of one to three deaths per 1,000 cases. The state’s public health messaging has highlighted the risk posed by declining vaccination rates, which have contributed to a resurgence of measles cases nationwide.

Following the confirmation of the deaths, Governor Josh Shapiro announced expanded response efforts to contain the outbreak and protect residents. The administration outlined a statewide strategy to address the spread, urging anyone exposed or showing symptoms to contact a health care provider or call the state hotline at 877-PA-HEALTH (877-724-3258). The Department of Health said it is working to provide timely information and resources to Pennsylvanians throughout the outbreak.

Nationally, the Pennsylvania fatalities are notable as the first measles deaths reported in the United States in 2026. Reuters reported that the deaths coincide with the highest U.S. measles case count in more than three decades. The Pennsylvania governor’s office confirmed these are the state’s first measles deaths since 1991. Media coverage has framed the fatalities as part of a larger outbreak rather than isolated incidents, reflecting a broader resurgence of measles linked to decreased vaccination coverage.

The outbreak’s origins trace back to late April 2026 in Lebanon County, with subsequent spread to neighboring counties. By late June, six counties had reported confirmed cases, including Berks, Dauphin, Lancaster, Lebanon, Northumberland, and York. State officials continue to monitor the situation closely and update public health guidance as the outbreak evolves.

The approval of LISRAYA (brepocitinib) marks the first targeted oral therapy authorized by the U.S. Food and Drug Administration specifically for adults with dermatomyositis, a rare autoimmune disease characterized by muscle weakness and a painful skin rash, according to the Muscular Dystrophy Association (MDA). The FDA granted approval on August 27, 2026, following the agency’s acceptance of Priovant Therapeutics’ New Drug Application with Priority Review in March 2026. The Prescription Drug User Fee Act target action date was set for the third quarter of 2026, and Priovant anticipates launching the drug in the United States by the end of September 2026.

Patients receiving brepocitinib 30 mg achieved a 15.3-point greater improvement in mean Total Improvement Score compared to placebo (46.5 vs. 31.2; P<0.001), according to published data and company summaries.

Brepocitinib, marketed under the brand name LISRAYA, is a once-daily 30 mg oral therapy that acts as a TYK2/JAK1 inhibitor, targeting specific signaling pathways involved in autoimmune and inflammatory diseases, according to Priovant Therapeutics and clinical trial data. This mechanism distinguishes it from traditional steroid-based immunosuppressants commonly used in dermatomyositis treatment, which often have incomplete efficacy and significant side effects.

The FDA’s decision was based on results from the pivotal Phase 3 VALOR trial, which enrolled 241 patients at 90 sites worldwide. The primary endpoint was the mean Total Improvement Score (TIS) at week 52, a composite index measuring disease activity across multiple domains. Patients receiving brepocitinib 30 mg achieved a 15.3-point greater improvement in mean TIS compared to placebo (46.5 vs. 31.2; P<0.001), according to published data and company summaries. The 15 mg dose showed a smaller, statistically non-definitive difference versus placebo. Institutional commentary on the VALOR trial noted that nearly 70% of patients on the 30 mg dose achieved moderate or greater improvement, with almost half reaching major improvement in disease activity.

Additional clinical outcomes from the VALOR study demonstrated that brepocitinib 30 mg provided significant benefits in skin disease severity, functional disability, and glucocorticoid tapering. Among patients with moderate-to-severe skin involvement, 44% on the 30 mg dose achieved cutaneous clinical remission by week 52, compared with 21% on placebo, according to Medscape reporting. The drug also showed improvements in the Cutaneous Dermatomyositis Area and Severity Index, motor strength, and the Health Assessment Questionnaire Disability Index. The ability to reduce reliance on systemic glucocorticoids was highlighted, with 62% of patients on brepocitinib 30 mg achieving a steroid dose of 2.5 mg per day or less by the end of the study, compared to 34% on placebo. Additionally, 42% of patients on brepocitinib discontinued steroids completely by week 52, versus 23% in the placebo group.

Safety data from the VALOR trial indicated a higher incidence of serious infections in the brepocitinib 30 mg group compared to placebo (10% vs. 1%), although no deaths occurred during the study period. The TYK2/JAK1 inhibitor mechanism carries class-specific risks, including infection, which was emphasized in expert commentaries and trial summaries. Despite the increased risk of serious infections, the overall safety profile was described as manageable in patients with refractory dermatomyositis.

Dermatomyositis has historically been treated with systemic glucocorticoids and broad immunosuppressants, which often provide incomplete disease control and carry significant side effects, according to medical literature and prior treatment guidelines. The MDA welcomed the FDA approval of LISRAYA as a major advance, calling it the first targeted therapy approved specifically for adults living with dermatomyositis. Roivant Sciences, through its affiliate Priovant Therapeutics, is the developer and sponsor of brepocitinib for this indication. Media coverage on August 27, 2026, including reports by STAT and Medscape, described the approval as a notable milestone in rare autoimmune disease therapeutics.

The VALOR trial’s positive results and the FDA’s approval signal a potential shift in the treatment landscape for dermatomyositis, offering an oral, targeted option where none previously existed. Further post-marketing surveillance and real-world data will be needed to monitor long-term safety and effectiveness as brepocitinib becomes available to patients.