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.

The recall involves approximately 1.6 million cartons, or nearly 19 million individual eggs, produced and distributed by Midwest Poultry Services, L.P., a company based in North Manchester, Indiana, with affected farms located in Texas, according to FDA records. The eggs subject to the recall were produced between June 6 and July 3, 2026, and include both white and brown cage-free shell eggs. The cartons bear sell-by or best-by dates ranging from July 20 through August 17, 2026, and specific plant and lot identifiers—codes P-1950 or 0840962 with Julian dates 157 through 184—printed on the side of the packaging, officials said.

Federal and state health agencies have linked the recalled eggs to 98 laboratory-confirmed cases of Salmonella Enteritidis infection across 17 states, according to data from the Centers for Disease Control and Prevention and the FDA.

Among those infected, 26 people have been hospitalized, but no deaths have been reported to date, media summaries of agency data show. Epidemiological investigations and laboratory testing have traced the outbreak to the implicated egg lots, with FDA officials stating that the recalled shell eggs are a likely source of the illnesses.

The FDA elevated the recall to its highest-risk Class I designation in mid-August 2026, following a thorough risk assessment of the outbreak data. FDA defines a Class I recall as one where there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The agency issued an enforcement report and safety alert formalizing the reclassification around August 14, 2026, emphasizing that the upgrade reflects a risk determination and does not necessarily expand the scope of Midwest Poultry Services’ original voluntary recall.

Midwest Poultry Services initiated the voluntary recall in July 2026 after identifying potential contamination with Salmonella Enteritidis in its Texas-produced eggs. The recall affects distribution primarily across parts of the U.S. South and Southwest, as well as other regions served by the company’s supply chain, FDA and CDC sources confirmed. Retailers and distributors in the impacted areas have been instructed not to sell or serve the recalled eggs and to follow FDA guidance on proper handling and disposal.

The ongoing investigation is a joint effort between the FDA, CDC, and state and local health departments. It relies on epidemiological interviews with affected individuals, laboratory testing of clinical and food samples, and supply-chain traceback from retail points back to the farms, according to FDA’s outbreak investigation documentation. While the agency has identified Midwest Poultry Services’ shell eggs as a likely source, officials noted that the investigation remains open and could expand if additional sources are implicated.

Public health authorities have issued consumer guidance advising against consumption of any eggs falling within the recalled brand, code, and date ranges. Consumers are urged to check the sell-by or best-by dates and the plant and Julian codes printed on egg cartons. Salmonella infection symptoms typically include fever, diarrhea—which may be bloody—nausea, vomiting, and abdominal pain. Health officials warn that infection can be serious or fatal, particularly for young children, older adults, and individuals with weakened immune systems. Although thorough cooking and proper food handling can reduce risk, FDA and CDC stress that recalled eggs should not be consumed even if cooked.

This recall follows a pattern of recurring salmonella-related egg investigations and recalls overseen by the FDA in recent years, including cases involving August Egg Company and Country Eggs in 2025. The agency’s approach in this instance—conducting a multistate outbreak investigation, maintaining a public outbreak dashboard, and escalating the recall to Class I—aligns with standard federal protocols for managing high-risk foodborne illness outbreaks involving widely distributed products. The FDA continues to monitor the situation and will update guidance as the investigation progresses.

The new acute care teaching hospital will serve as the centerpiece of a multi-phase health and mixed-use campus spanning roughly 40 acres at 675 Metropolitan Parkway SW in Atlanta’s West End neighborhood, according to Atrium Health and Morehouse School of Medicine officials. The project includes plans for a Level III trauma center, outpatient clinics, virtual care services, and coordinated network elements designed to improve access across Central and South Fulton County, sources confirmed.

Atrium Health, part of Advocate Health, has committed more than $700 million in capital and clinical investment for the hospital and the broader integrated care network, which aims to deliver acute, primary, specialty, and emergency care to underserved communities in South and West Atlanta.

The hospital is initially expected to open with about 50 beds, with capacity to expand to more than 700 beds as development progresses. City planning documents and local reports have referenced a potential Level II trauma center with up to 125 beds as part of the evolving project scope, reflecting ongoing refinements in capacity goals. Atrium Health filed a Letter of Determination with the Georgia Department of Community Health on June 18, 2026, seeking approval to build the teaching hospital, which will include a 24/7 emergency department and trauma services, officials said. The facility is anticipated to open by around 2030, contingent on regulatory approvals and funding commitments, according to local coverage.

The partnership between Atrium Health and Morehouse School of Medicine is aimed at addressing longstanding healthcare access gaps in Atlanta’s southside and westside neighborhoods, areas that have experienced systemic disinvestment in healthcare infrastructure, according to statements from both organizations. Morehouse School of Medicine will anchor the academic mission of the hospital, integrating medical education and research with clinical operations. Atrium Health will provide clinical management and capital investment for the facility and its network. The campus location near the West End MARTA Station and the Atlanta BeltLine, adjacent to MSM’s main campus, is intended to facilitate coordination between clinical services and academic programs.

Atrium Health acquired the 40-acre Metropolitan Parkway site in fall 2024 for nearly $70 million, positioning the property for the hospital project well before the formal partnership announcement in August 2026. City of Atlanta officials have publicly committed approximately $100 million to $115 million in support of the hospital infrastructure through tax allocation districts and other funding mechanisms. The Atlanta City Council unanimously passed resolutions endorsing the project and urging Fulton County to contribute $200 million, typically framed as $20 million annually over 10 years, to complement the investments from Atrium Health, Morehouse School of Medicine, and the city, according to council records and local news reports.

The hospital will be the only acute care facility south of Interstate 20 in Atlanta, a fact underscored by city leaders who have emphasized the project’s strategic importance for emergency care and inpatient services in the region. The broader initiative, sometimes referred to as “Project Robin,” is viewed by local officials as a critical step in rebuilding hospital infrastructure after prior closures in southern Atlanta. While the City of Atlanta and private partners have made substantial financial commitments, Fulton County’s formal approval of the requested $200 million remains pending as of mid-2026, with county leaders considering integration of the funding into existing hospital bond structures.

Officials from Atrium Health and Morehouse School of Medicine have highlighted the project’s dual focus on improving health equity and expanding the medical workforce pipeline. The integrated care network will include outpatient primary care, urgent care, and specialty clinics, along with virtual care services, to bring high-quality healthcare closer to residents in historically marginalized communities. The partnership aims to create expanded educational and workforce opportunities for Atlanta and Fulton County residents, supporting the training of physicians and health professionals in the region.

The development is planned as a transformative, multi-phase mixed-use campus that will integrate healthcare delivery, medical education, research, and community spaces. State filings and local planning documents describe the hospital and its associated clinics as part of a coordinated network designed to address significant healthcare disparities in Central and South Fulton County. The project’s timeline and scope remain subject to regulatory review and funding approvals, with construction and phased expansion expected to continue through the next decade.

The study tracked more than 2,300 participants who used psilocybin services in Oregon’s state-regulated or community settings, making it one of the largest prospective naturalistic datasets on psilocybin to date, according to Oregon Health & Science University officials. Among those completing follow-up surveys, 50 to 60 percent experienced at least a 50% reduction in these symptoms, officials said. These findings align with prior clinical trials that have documented sustained reductions in depressive symptoms following single-dose psilocybin treatment for major depressive disorder.

Researchers reported that depression and anxiety scores, measured by the PHQ-9 and GAD-7 scales, dropped by about 50% within two weeks of dosing.

The OHSU-led research also found that participants reported decreased moderate-to-severe anxiety and reduced post-traumatic stress disorder symptoms at three months post-treatment. Improvements were not limited to symptom relief; participants indicated enhanced mental well-being and life satisfaction over the same period. According to the study, these outcomes suggest psilocybin’s potential benefits extend across a range of mood and trauma-related conditions. A large, independent naturalistic survey published in *Frontiers in Psychiatry* corroborated these results, showing enduring reductions in anxiety, depression, and alcohol misuse, alongside increased cognitive flexibility and spiritual well-being.

Safety data from the study were drawn from a multisite cohort of 346 adults receiving psilocybin services under OHSU supervision. Serious adverse reactions were uncommon, officials said, with only about 1% of participants experiencing serious negative mental health impacts. Among these, four first-time users required medical attention for acute behavioral reactions, illustrating that while rare, serious events can occur. Overall, longitudinal data from Oregon’s regulated psilocybin services indicated the treatments were generally safe and associated with improved mental health outcomes. These real-world safety findings are consistent with a broader systematic review and meta-analysis of psychedelics for mental disorders, which reported favorable safety profiles and few lasting negative effects.

Participant experiences were also documented. At one month post-treatment, 91.5% of participants reported benefiting from psilocybin, and 64.9% ranked the experience among the 10 most meaningful of their lives, according to OHSU records. These subjective reports of benefit and meaning persisted at three months, with continued improvements in mental well-being and life satisfaction. The broader naturalistic survey similarly found that most participants described ongoing mental health improvements and increased spiritual well-being, though a minority reported lingering negative effects such as mood fluctuations or residual depressive symptoms.

The OHSU psilocybin services program began in January 2023 following Oregon’s passage of pioneering psilocybin legislation. The program offers psilocybin-assisted therapy through licensed facilitators for patients experiencing depression and anxiety related to life-threatening illness. A February 12, 2026, OHSU news release detailed the research initiative, noting preliminary data from more than 300 clients and a goal to enroll at least 1,600 participants over five years. The study recruits through a statewide network of 31 licensed service centers and 350 facilitators, with participants followed for up to one year after dosing to assess both short- and longer-term mental health trajectories, officials said.

The OHSU findings are consistent with recent controlled clinical trials. A 2023 study published in *JAMA* found that single-dose psilocybin treatment for major depressive disorder produced clinically significant, sustained reductions in depressive symptoms and functional disability without serious adverse events. Open-label pilot studies on treatment-resistant depression reported large effect sizes and response or remission rates around 43%, providing a benchmark comparable to the improvements observed in the OHSU real-world cohort. Long-term follow-up from other psilocybin trials has shown that approximately two-thirds of participants remained in remission up to five years post-treatment.

In contrast, recent controlled research on psilocybin microdosing found no reliable cognitive or emotional benefits beyond placebo, according to study authors. This suggests that the high-dose, facilitated sessions used in the OHSU program are the primary drivers of observed mental health improvements. A 2024 systematic review and meta-analysis of psychedelics for mental disorders concluded that these substances show promising efficacy and a favorable safety profile, situating the OHSU real-world study within a growing body of converging evidence.

OHSU neuroscientist Adie Rae and colleagues have emphasized that the program aims to better understand psilocybin’s effects on mental health, substance use, and well-being in large, real-world samples, complementing controlled clinical trial data. The ongoing research will continue to monitor participants over time to provide further insights into the durability and scope of psilocybin’s therapeutic effects.

The Health Products Regulatory Authority (HPRA) in Ireland announced a recall of all remaining Tavneos stock at the wholesale level on Aug. 20, 2026, following the European Medicines Agency’s (EMA) conclusion that the drug’s benefits no longer outweighed its risks. The recall came after the EMA’s June 2026 reassessment and the European Commission’s endorsement of the recommendation to revoke Tavneos’ marketing authorization across the European Union in August 2026, officials said. Tavneos had been authorized in Ireland for adults with severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), both rare inflammatory diseases of small blood vessels, according to HPRA records.

Kissei issued a safety notice on May 15, 2026, reporting about 20 deaths linked to serious liver dysfunction, including cases of vanishing bile duct syndrome (VBS), a severe form of drug-induced liver injury (DILI).

The decision followed safety concerns arising from reports in Japan, where Tavneos was launched in 2022 and has since been used to treat approximately 8,500 patients, according to Kissei Pharmaceutical, which manages the drug’s sales and distribution in Japan. The company warned of the risk of severe liver dysfunction and advised physicians to stop initiating new Tavneos treatments and to closely monitor liver function in ongoing patients, discontinuing the drug if abnormalities appeared.

Alongside the fatalities, Kissei reported at least 22 patients developing potentially fatal liver injuries while on Tavneos. However, both Kissei and Amgen, the drug’s international marketer, stated that a direct causal relationship between Tavneos and all reported deaths has not been definitively established, according to company statements and safety notices. Despite this, the severity and number of liver-related adverse events prompted regulators to take precautionary measures.

Following the Japanese safety alerts, U.S. regulators reportedly requested that Amgen voluntarily withdraw Tavneos from the American market, although the majority of deaths and liver injury cases have been documented in Japan, media reports indicated. In Europe, the EMA’s review incorporated the Japanese safety data and broader pharmacovigilance assessments, leading to its conclusion that Tavneos’ benefit-risk balance was no longer favorable. The European Commission subsequently endorsed the EMA’s recommendation to revoke the marketing authorization, effectively removing Tavneos from the EU market.

Ireland ceased distribution of Tavneos from wholesalers on Aug. 11, 2026, ahead of the HPRA’s formal recall request. France’s medicines safety agency also announced on Aug. 19, 2026, that Tavneos would be withdrawn from the French market, citing the same link to approximately 20 deaths in Japan. French authorities emphasized the drug’s use in treating severe active ANCA-associated vasculitis, a group of rare autoimmune diseases similar to those targeted in Ireland and elsewhere in Europe.

The recalls and market withdrawals across the EU affect patients with rare autoimmune diseases who relied on Tavneos for treatment. Health authorities in Ireland and other countries are expected to provide guidance to clinicians on alternative therapies and patient management following the drug’s removal from the market.

Kissei and regulatory agencies continue to stress the importance of regular liver function monitoring in patients who have been treated with Tavneos and recommend immediate discontinuation if liver abnormalities are detected. While new prescriptions of Tavneos were temporarily discouraged in Japan following the initial safety notice, Japanese guidance later allowed treatment to resume under stricter liver safety warnings. In contrast, European regulators opted for market withdrawal rather than restricted use, citing the overall negative benefit-risk profile.

Tavneos is indicated for severe active granulomatosis with polyangiitis and microscopic polyangiitis, both forms of ANCA-associated vasculitis characterized by inflammation of small blood vessels. The drug is marketed internationally by Amgen, with Kissei Pharmaceutical responsible for sales in Japan. The reported cluster of liver-related deaths and injuries in Japan since Tavneos’ 2022 launch prompted the global regulatory response culminating in the recent recalls and authorization revocations.

Tauklarify, developed by Lantheus Holdings Inc., is administered intravenously before positron emission tomography (PET) brain scans to detect tau neurofibrillary tangle (NFT) pathology in adults with cognitive impairment who are undergoing evaluation for Alzheimer’s disease, according to FDA documents released in August 2026. The FDA’s approval, announced around August 13–14, 2026, makes Tauklarify the second tau PET imaging agent authorized by the agency, following the 2020 approval of flortaucipir F 18 (Tauvid).

The radiotracer, florquinitau F 18, binds selectively to aggregated tau protein in neurofibrillary tangles, a hallmark of Alzheimer’s pathology that correlates with neuronal degeneration and symptom severity, FDA officials said.

Using fluorine-18 as the radionuclide, which has a half-life of about 110 minutes, Tauklarify can be produced centrally and distributed regionally to imaging centers, similar to other F-18 PET agents. PET scans obtained with Tauklarify are interpreted visually or quantitatively to classify the presence or absence of tau pathology based on standardized criteria established in clinical trials and labeling.

Clinical studies supporting the approval demonstrated that PET images with Tauklarify correlate with post-mortem measures of tau pathology, mirroring the evidentiary framework used for the first approved tau tracer, Tauvid. The FDA’s decision was based on prospective trials involving adults with varying degrees of cognitive impairment, from mild cognitive impairment to dementia, suspected of having Alzheimer’s disease. These trials showed a high likelihood that trained evaluators could accurately identify tau pathology from PET scans compared with neuropathology reference standards, records show.

Tauklarify is intended to be used as an adjunct to other clinical evaluations, including patient history, cognitive testing, and other imaging modalities, rather than as a stand-alone diagnostic tool, according to FDA labeling. Its role parallels that of amyloid PET tracers such as Amyvid (florbetapir F 18), Neuraceq (florbetaben F 18), and Vizamyl (flutemetamol F 18), which are approved for imaging beta-amyloid neuritic plaques. However, Tauklarify specifically targets tau pathology, a distinct hallmark of Alzheimer’s disease, providing complementary information that can aid in differential diagnosis, disease staging, and potentially treatment selection as tau- and amyloid-targeting therapies expand in clinical practice.

The FDA’s approval of Tauklarify follows the agency’s acceptance of a New Drug Application for MK-6240, the investigational tau PET imaging agent developed by Lantheus, with a targeted Prescription Drug User Fee Act (PDUFA) date in August 2026. Lantheus is a radiopharmaceutical company focused on imaging agents for disease identification and management, including Alzheimer’s disease, company records confirm.

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) noted that Tauklarify’s approval “adds a second FDA-approved tau tracer alongside flortaucipir F-18 (Tauvid),” highlighting its significance for nuclear medicine and dementia imaging practice. Regulatory announcements emphasize that tau PET agents like Tauklarify are intended for use exclusively in adults with cognitive impairment undergoing evaluation for Alzheimer’s disease, with labeling designed to ensure appropriate patient selection and interpretation to avoid misuse outside the indicated population.

The approval expands clinicians’ ability to directly visualize tau pathology in vivo, enhancing diagnostic precision for patients presenting with cognitive impairment, according to experts cited by the FDA. The availability of both tau and amyloid PET imaging agents allows for a more comprehensive assessment of Alzheimer’s pathology, supporting refined diagnostic classification and potentially more tailored therapeutic strategies, especially as disease-modifying treatments targeting tau and amyloid proteins emerge in clinical practice.

Amyloid PET tracers have a longer regulatory history, with Amyvid first approved as a radioactive diagnostic agent for brain imaging of amyloid plaques. Its label indicates that a negative scan reduces the likelihood that cognitive impairment is due to Alzheimer’s disease, while a positive scan indicates moderate to frequent amyloid neuritic plaques that may also occur in other conditions. More recently, the FDA approved expanded indications for several amyloid PET agents, including an updated label for Vizamyl in June 2025, reflecting broader acceptance of PET imaging in Alzheimer’s evaluation.

Post-approval, further data collection on Tauklarify’s clinical use is expected through real-world studies and possibly post-marketing requirements, as the tracer becomes integrated into Alzheimer’s diagnostic and research workflows, FDA sources said. Adoption of tau PET imaging in routine clinical pathways will depend on factors such as reimbursement policies, access to PET imaging facilities, and clinician familiarity with interpreting tau and amyloid PET scans, industry analysts noted.

The approval covers a prescription metered nasal spray formulation indicated for the treatment of nasal symptoms associated with allergic rhinitis, including seasonal and perennial forms, officials said. The agency determined the product to be bioequivalent and therapeutically equivalent to the reference listed drug under an Abbreviated New Drug Application (ANDA), as confirmed by DailyMed labeling and marketing status records.

The FDA approved Glenmark’s Fluticasone Propionate Nasal Spray USP, 0.05 mg per spray, as a generic equivalent to Haleon US Holdings LLC’s Flonase Nasal Spray, according to Glenmark Pharmaceuticals Limited’s announcement on August 20, 2026.

The approved generic delivers 50 micrograms of fluticasone propionate per 100-milligram spray, consistent with the dosing strength of Flonase Nasal Spray, according to DailyMed drug information. The nasal spray is intended for local intranasal administration and is formulated to minimize systemic glucocorticoid exposure relative to oral corticosteroids, officials noted. Fluticasone propionate is classified pharmacologically as a glucocorticoid corticosteroid and is commonly used once or twice daily for intranasal corticosteroid therapy, although specific dosing schedules are determined by the approved product label.

Glenmark’s approval expands its portfolio of U.S. generic corticosteroid nasal sprays, adding a technically demanding dosage form to its ANDA pipeline, industry sources said. The company had previously received final FDA approval for an over-the-counter (OTC) fluticasone propionate nasal spray USP, 50 mcg per spray, on March 19, 2026. That OTC product, marketed as bioequivalent to Flonase Allergy Relief, is associated with ANDA 218742 and is distributed in the United States by Glenmark Therapeutics Inc., USA, according to company communications and DailyMed records.

The newly approved prescription spray competes in a market where Flonase has been a leading brand for nasal corticosteroids. Glenmark emphasized in its public statements that the FDA’s determination of bioequivalence and therapeutic equivalence strengthens its position in the U.S. generics market. Glenmark’s broader respiratory portfolio also includes other fluticasone propionate generics, such as the FDA-approved generic of Flovent HFA inhalation aerosol 44 mcg per actuation, which received competitive generic therapy exclusivity in March 2026.

The FDA approval documentation and Glenmark’s press materials confirm that the product is non-controlled and carries no DEA schedule. The nasal spray is indicated for nasal symptoms of allergic rhinitis and perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older, consistent with standard fluticasone propionate nasal spray labeling found on DailyMed. These indications include relief from runny nose, nasal congestion, sneezing, and nasal itching.

Trade and healthcare media outlets reported Glenmark’s August 20 announcement as the company “getting FDA nod” for the generic fluticasone propionate nasal spray. Glenmark’s North America unit reiterated the FDA approval on LinkedIn, noting distribution plans for the OTC product through Glenmark Therapeutics Inc., USA. Regulatory data also show international activity around fluticasone propionate nasal sprays, including a product branded as Flusort approved by the Philippines FDA in March 2025, although this is unrelated to the U.S. generic approval.

The FDA’s approval of Glenmark’s generic fluticasone propionate nasal spray under the ANDA pathway reflects ongoing regulatory processes to expand access to generic corticosteroid nasal sprays in the U.S. market. Glenmark’s announcement followed established protocols for generic drug approvals, including demonstration of bioequivalence and therapeutic equivalence to the reference listed drug. The company’s expanding ANDA portfolio underscores its focus on inhaled and nasal steroid platforms within the respiratory therapeutic area.