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.

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.

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.

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.

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.

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.