The FDA granted accelerated approval to ravulizumab-cwvz to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.
Approval was based on the phase 3 I CAN trial, in which ravulizumab reduced proteinuria by 46.6% at week 34, compared with 5.6% with placebo.
Whether ravulizumab slows kidney function decline has not been established; the ongoing I CAN trial will assess eGFR change at week 106.
The most frequently reported adverse events with ravulizumab were upper respiratory tract infection, nasopharyngitis, and infusion-related reactions.
Ravulizumab carries a boxed warning for serious meningococcal infections, and the FDA advises vaccination before treatment unless delaying therapy poses greater risks.
Objective: To develop and evaluate a programmable 4D bio-Kirigami system for shaping cell-laden hydrogel constructs and assessing whether cartilage-like matrix
Researchers developed a 4-dimensional bio-Kirigami system combining a deformable, cell-laden hydrogel with a more rigid outer hydrogel ring.
Human mesenchymal stem cell–laden constructs formed dome-shaped curvatures during 21 days of culture in both expansion and chondrogenic conditions.
After removal of the outer ring, constructs cultured under chondrogenic conditions retained their dome shape for 6 days, whereas expansion-medium constructs gradually collapsed.
Chondrogenic constructs had greater glycosaminoglycan content, stronger Alcian blue and type II collagen staining, and higher DNA content than controls.
The study was limited by small cartilage-test samples, 6-day postremoval follow-up, and the absence of implantation or in vivo testing.
A girl with estrogen-related changes beginning at 4 months had recurrent vaginal bleeding, advanced bone age, severe anemia, and endometrial abnormalities by age 6 years and 7 months.
Whole-exome sequencing identified a likely pathogenic ESR1 p.Tyr537Ser variant, while suppressed luteinizing hormone argued against central precocious puberty; causation remains unconfirmed.
Tamoxifen temporarily reduced the cervicovaginal mass and improved symptoms, but recurrence was documented by February 2025, prompting combined letrozole–tamoxifen therapy.
The case report authors noted that the long-term malignancy risk is unknown, and the unusually early puberty’s relationship to excessive estrogen receptor activity remains uncertain.
The report described atypical endometrial hyperplasia/endometrioid intraepithelial neoplasia in a child, an extraordinarily unusual finding in childhood.
Objective: To describe a case of choroidal detachment occurring after changes to continuous positive airway pressure (CPAP) therapy and discuss a possible relat
A 76-year-old man developed left-eye choroidal detachment about 7 weeks after his CPAP pressure was increased and a new, less-leaky mask was introduced.
The detachment progressed to a kissing configuration, with visual acuity declining to hand movements and intraocular pressure rising to 27 mm Hg.
The patient received topical dexamethasone and cyclopentolate, followed by dorzolamide plus timolol; CPAP therapy continued during ocular recovery.
The choroidal detachment had completely resolved anatomically by week 16, while visual acuity and intraocular pressure improved.
The authors proposed that greater effective positive airway pressure might impair choroidal venous drainage, but this single case could not establish causation.
Objective: To describe the diagnosis and clinical course of a giant intrapulmonary solitary fibrous tumor (SFT) in a 57-year-old woman. Approach: Diagnostic eva
Objective: The interview with food chemist Francesco Cacciola discusses recent developments in food analysis, his group’s research, current analytical challenge
High-resolution mass spectrometry combined with advanced chromatography has expanded targeted and untargeted analysis of food metabolites and bioactive compounds.
Green analytical approaches include miniaturized sample preparation, solvent-free extraction, and less toxic solvents to reduce resource use.
Chemometrics, machine learning, and AI-assisted workflows help interpret complex food-analysis datasets and identify quality patterns.
Food analysis still faces challenges in comprehensive coverage, quantitative accuracy, and standardization across laboratories and studies.
Cacciola anticipates closer integration of chromatography, high-resolution mass spectrometry, and AI, alongside development of real-time food-analysis tools.
Objective: The article describes FDA–TransCelerate tabletop exercises on pragmatic clinical trials and selective safety data collection (SSDC), and discusses th
TransCelerate and FDA CDER used hypothetical trials across four disease areas and regulatory settings to explore pragmatic trial design and selective safety data collection.
The tabletop exercises brought together FDA medical reviewers, statisticians, inspection experts, and policy specialists to discuss trial design and implementation.
Participants discussed targeted data collection and safety monitoring, including selective safety data collection for medicines with mature life cycles and potential new indications.
DiCicco said automation can reduce manual data handling and help research professionals identify potential safety signals sooner, but easier collection can also increase data burden.
Sponsors face myths and uncertainty about regulators’ views of selective safety data collection, while FDA C3TI research has examined whether its use could have affected study findings.
Gross specimens vary in size, shape, orientation, texture, and clinical context, making them harder to digitize than standardized glass slides.
Digital grossing trends include intake technologies for documenting specimens, integration tools that connect information, and computational intelligence.
An integrated digital system could link specimen images, measurements, annotations, and sampling details throughout the pathology workflow.
Digital tools could improve measurement, structured documentation, and consistency while automating repetitive tasks such as calculations.
Technology should support, not replace, professional judgment; laboratory professionals must be able to understand, question, and override it.
Objective: To investigate the genetic and biochemical basis of retinitis pigmentosa in individuals with variants affecting both copies of IDUA. Approach: Partic
Researchers identified biallelic IDUA variants in 14 people from 12 families with retinitis pigmentosa.
Seven participants aged 46 to 73 years had no systemic features consistent with mucopolysaccharidosis type I after clinical evaluation.
Testing in nine individuals found detectable but greatly reduced α-L-iduronidase activity, with some variants retaining 0.5% to 1.5% of normal activity.
Long-read RNA sequencing showed that a recurrent IDUA variant caused abnormal splicing, despite little apparent impact in conventional protein-based testing.
The authors recommend including IDUA and other MPS-associated genes in inherited retinal disease panels and pursuing biochemical follow-up when both gene copies carry variants.
Objective: To investigate the genetic and biochemical basis of retinitis pigmentosa in individuals with variants affecting both copies of IDUA. Approach: Partic
Researchers identified biallelic IDUA variants in 14 people from 12 families with retinitis pigmentosa.
Seven participants aged 46 to 73 years had no systemic features consistent with mucopolysaccharidosis type I after clinical evaluation.
Testing in nine individuals found detectable but greatly reduced α-L-iduronidase activity, with some variants retaining 0.5% to 1.5% of normal activity.
Long-read RNA sequencing showed that a recurrent IDUA variant caused abnormal splicing, despite little apparent impact in conventional protein-based testing.
The authors recommend including IDUA and other MPS-associated genes in inherited retinal disease panels and pursuing biochemical follow-up when both gene copies carry variants.
Objective: To create a standardized, large-scale mass spectrometry dataset for developing and evaluating artificial intelligence models in proteomics. Approach:
MassNet standardizes 1.54 billion tandem mass spectra from 648 projects, 27,643 runs, and 35 animal, plant, and microbial species.
Reanalysis with FragPipe and Sage yielded 548 million peptide-spectrum matches, 2.54 million unique peptides, and 133,422 proteins.
The MSDT format stores spectra with peptide identifications and experimental metadata, and its files were approximately 82% smaller than the source files.
Trained on 100 million peptide-spectrum matches, XuanjiNovo outperformed five other de novo sequencing models in a 15-species benchmark.
MassNet includes only spectra identified by FragPipe or Sage and does not systematically cover modifications such as phosphorylation, glycosylation, or ubiquitination.
Objective: The article examines the objective, findings, and clinical context described in Authors’ response to comments on MAPSE in critical illness: translati
Reduced MAPSE alone should not trigger inotropic therapy; treatment decisions should reflect the patient’s overall hemodynamic and clinical status.
The study assessed MAPSE feasibility and prognostic value across a heterogeneous ICU population, viewing it as a bedside risk-stratification marker alongside other findings.
After adjustment for age, SAPS 3, and cardiac index, lower MAPSE remained independently associated with 90-day mortality, whereas LVEF did not.
MAPSE measurement was substantially more feasible than Simpson biplane LVEF measurement in this critically ill population.
The authors retained patients with mitral annular calcification and called for studies with prespecified etiologic strata, interaction analyses, and serial echocardiography.
The Employer Health Benefits Survey has tracked employer-sponsored health insurance trends since 1999 among private and nonfederal public employers with at least 10 employees.
The survey reports premiums, defined as the full per-person cost of coverage, and worker contributions, defined as the portion paid by workers.
Premium and worker contribution estimates are weighted by the number of workers receiving health benefits and adjusted for industry and firm size.
Standard errors quantify estimate uncertainty, which generally increases for smaller groups; differences between estimates may not be statistically significant.
Family coverage represents coverage for a four-person family, and firms offering multiple plan types are classified by their largest plan type.
Objective: The article reports findings from KFF’s 2026 Employer Health Benefits Survey, including worker contributions to family premiums, total premiums, empl
Workers contributed an average of $7,471 annually toward employer-sponsored family premiums in 2026, up $621, or 9%, from 2025.
Including employer contributions, average annual family premiums reached $28,303 in 2026, a 5% increase from 2025.
At small firms, employees contributed an average of $9,687 annually for family coverage, $2,847 more than employees at large firms.
From 2021 to 2026, family premiums rose 28% and workers’ contributions rose 26%, compared with wage growth of 27% and inflation of 24%.
Among large employers, 44% increased workers’ premium contributions in response to higher anticipated health expenses, and 21% raised deductibles or other cost sharing.
Objective: The article examines the objective, findings, and clinical context described in What Growth Is Projected for U.S. Health Spending?. Approach: Project
U.S. health spending is projected to reach $6.0 trillion in 2026, or 18.7% of the economy.
Hospitals are projected to account for the largest share of 2026 health spending, at $1.9 trillion.
Health spending is projected to rise to $9.0 trillion by 2034, exceeding one-fifth of the U.S. economy.
Annual health spending growth is projected at 6.3% in 2026 and 4.7% in 2027.
Medicaid changes, the expiration of enhanced ACA Marketplace premium tax credits, and Medicare drug provisions are projected to moderate spending growth.
Among ICU survivors, 10.0% of immunocompromised patients died before hospital discharge, compared with 4.0% of immunocompetent patients.
Post-ICU deaths accounted for approximately one-half of the absolute difference in in-hospital mortality between immunocompromised and immunocompetent patients.
The authors note that treatment limitations, late secondary infection, or progression of underlying disease could contribute to excess mortality after ICU discharge.
The SARI case definition and exclusion of patients with unknown immune status may have affected cohort composition, particularly for COVID-19 admissions.
Approximately three-quarters of the 11.0-point shortfall in 30-day discharge reflected excess hospital mortality rather than a greater proportion remaining hospitalized.