ONCOLOGY

The FDA's Accelerated Approval pathway, which has facilitated early access to new oncology drugs, is facing criticism and undergoing potential reforms. In March 2023, the FDA released draft guidance offering solutions to enhance the pathway and improve patient outcomes in cancer treatment. While the Accelerated Approval pathway has successfully granted early access to innovative cancer medications, it has faced scrutiny due to withdrawals of approved indications and delays in completing confirmatory studies. These delays have allowed drugs to remain on the market without demonstrating conclusive clinical benefits. The new guidance addresses these issues and optimises the program's effectiveness.

FDA Accelerated Approval Pathway for Oncology Drugs: Criticism, Reforms, and Enhancements for Improved Cancer Treatment Outcomes - March 2023 Draft Guidance

UROLOGY

The PART trial compares partial prostate ablation with radical treatment for localized intermediate-risk prostate cancer, assessing oncological outcomes and quality of life.

PART Trial: Partial Prostate Ablation vs Radical Treatment for Prostate Cancer

The UK-wide PART randomized controlled trial evaluates whether partial prostate ablation (PA), using high-intensity focused ultrasound (HIFU) or irreversible electroporation (IRE), provides non-inferior oncological treatment success compared with radical treatment (RT) for localized intermediate-risk prostate cancer. The study will compare treatment effectiveness, urinary and sexual side effects, health-related quality of life, serious adverse events and cost-effectiveness. The trial aims to generate prospective evidence to support treatment decision-making and evaluate whether partial ablation can offer an alternative to radical treatment.

PULMONOLOGY

Study identifies nasal polyposis and earlier asthma onset as predictors of response to IL-5 inhibitors in severe eosinophilic asthma.

IL-5 Inhibitors in Severe Eosinophilic Asthma: Predictors of Treatment Response

A retrospective cohort study evaluated real-world clinical and phenotypic predictors of treatment response to interleukin-5 (IL-5) pathway inhibitors in adults with severe eosinophilic asthma. The study included 128 patients treated with mepolizumab or benralizumab for at least 12 months between June 2019 and June 2025. Nasal polyposis and earlier age at asthma onset were independently associated with treatment response, while obesity and total IgE levels were not independently associated with response. The findings support phenotype-oriented approaches to biologic selection and personalized asthma management.

PEDIATRICS

Study examines associations between different types of screen time and developmental outcomes among children aged 0–6 years in Thailand.

Screen Time and Child Development: Associations with Developmental Delays in Thailand

A cross-sectional study investigated the associations between different types of screen time and developmental outcomes among children aged 0–6 years in Thailand. The study included 465 caregiver–child pairs, with 78.9% of children exceeding recommended screen time limits. Higher total and recreational screen time were associated with increased odds of suspected developmental delays, particularly receptive language and gross motor delays. Educational and communication-based screen time were associated with lower odds of delays in selected developmental domains. The findings highlight the importance of limiting recreational screen exposure and encouraging age-appropriate, interactive digital activities.

DENTISTRY

Randomized clinical trial compares 24-month partial pulpotomy outcomes using White MTA Angelus and NeoPutty in mature mandibular molars.

Partial Pulpotomy with MTA and NeoPutty: 24-Month Clinical Outcomes

A randomized clinical trial compared the clinical and radiographic outcomes of partial pulpotomy using White MTA Angelus and NeoPutty in mature mandibular molars with deep carious lesions and varying degrees of pulpitis. The study included 139 teeth, all of which completed the 24-month follow-up. Success rates were 90.6% for White MTA Angelus and 92.0% for NeoPutty, with no statistically significant difference between the groups. Haemostasis time was significantly associated with treatment outcome, whereas preoperative pulpal diagnosis was not.

Systematic review evaluates telemedicine-based parent training and its effects on communication, adaptive behaviour and caregiver well-being in autism.

Telemedicine Parent Training for Autism: Effects on Children and Caregivers

A systematic review evaluated the effectiveness of telemedicine-based parent training interventions for children with autism spectrum disorder (ASD) and their caregivers. Nineteen studies involving 616 children were included. Telemedicine interventions, including real-time video coaching, self-guided online modules and hybrid models, were associated with reduced parenting stress, improved parental self-efficacy and enhanced caregiver competence. Improvements were also observed in children's communication abilities, interaction and adaptive behaviours. The findings highlight telemedicine as a potential approach to expanding access to professional support, particularly for families in remote areas.

DERMATOLOGY

A conceptual framework introduces Target Treatment Zones for anatomy-guided, skin quality-focused aesthetic interventions using non-cross-linked hyaluronic acid.

Target Treatment Zones: A Skin Quality-Focused Aesthetic Treatment Framework

A conceptual clinical framework introduces Target Treatment Zones (TTZs) within the visual aesthetic methodology to support anatomy-guided, skin quality-focused interventions. The approach uses non-cross-linked hyaluronic acid combined with glycerol to address skin hydration and texture without intentionally altering facial volume or contour. Illustrative clinical cases demonstrated the practical application of zone-specific treatment planning, with observations suggesting potential improvements in hydration, skin texture and perceived skin quality. However, no formal efficacy analysis was performed, and further clinical research is needed to validate the framework.

Study examines consumer perceptions of facial skin glycation and expectations for anti-glycation skincare among Chinese women.

Consumer Perceptions of Glycation and Anti-Glycation Skincare in Chinese Women

A consumer research study investigated perceptions of glycation-related skin changes and expectations regarding anti-glycation skincare among women in China. The study included focus group discussions with 24 participants and an online survey involving 800 women aged 20–50 years. Participants primarily associated anti-glycation skincare with reduced dullness and yellowness, along with improved skin radiance and brightness. The findings highlighted “nourishing,” “repairing” and “skin and spot lightening” as key skincare categories linked to perceived anti-glycation benefits.

Ethnographic study explores caregiver perspectives and everyday practices shaping infant motor development in an urban Chilean setting.

Caregiver Practices and Cultural Influences on Infant Motor Development

A focused ethnographic study explored how caregivers interpret and incorporate early motor development practices into everyday caregiving routines. The study included 13 caregivers of infants younger than 18 months in an urban Chilean setting. Caregivers viewed motor development as essential for autonomy and daily functioning, while developmental activities were shaped by time constraints, safety concerns and available support networks. Stimulation commonly involved relational play, environmental adaptations and shared family routines. The findings emphasize the importance of context-sensitive and culturally responsive developmental guidance.

NEUROLOGY

Study investigates IL-1β-mediated inflammation and neutrophil extracellular trap formation during hyperacute large vessel occlusion stroke.

Hyperacute Stroke Inflammation: Role of IL-1β and Neutrophil Extracellular Traps

A study published in Annals of Neurology investigated the local inflammatory response in patients with large vessel occlusion stroke during the hyperacute phase. Using multiomics analysis of ischemic blood collected directly from the occluded middle cerebral artery in 54 patients undergoing mechanical recanalization, researchers identified activation of classical monocytes and neutrophils. IL-1β emerged as a key inflammatory mediator, accompanied by increased neutrophil-attracting chemokines and neutrophil extracellular trap (NET) formation. The findings highlight potential mechanisms contributing to early stroke pathophysiology and possible targets for immunomodulatory therapies.

A multicenter study identified AQP4 and MOG autoantibodies as dominant immune markers in ICI-induced optic neuritis, supporting diagnostic and classification strategies.

AQP4 and MOG Autoantibodies in ICI-Induced Optic Neuritis

A multicenter retrospective study published in Annals of Neurology identified aquaporin-4 (AQP4) and myelin oligodendrocyte glycoprotein (MOG) autoantibodies as the predominant immune markers in immune checkpoint inhibitor (ICI)-induced optic neuritis. Among 88 patients, AQP4/MOG seropositivity ranged from 17.3% to 32.4% across cohorts, while these antibodies were nearly absent in control patients. Longitudinal analysis demonstrated antibody emergence around symptom onset, supporting their potential diagnostic and classification value.

The Göteborg-2 trial found that PSA density stratifies long-term prostate cancer risk after negative MRI, supporting risk-adapted follow-up with continued PSA monitoring.

PSA Density Predicts Prostate Cancer Risk After Negative MRI

A pre-specified analysis of the population-based Göteborg-2 screening trial evaluated whether prostate-specific antigen density (PSAD) could guide follow-up after a negative prostate MRI. Among 1,685 men followed for a median of 5.5 years, the 7-year cumulative incidence of clinically significant prostate cancer (csPCa) was 7.1% overall. Risk was lowest among men with PSAD <0.10 ng/mL², although clinically significant cancers still occurred in this group. A PSAD-guided strategy could reduce MRI use by 60% and biopsies by 46%, but may delay some csPCa diagnoses, highlighting the need for continued PSA-based monitoring.

The CHIMES phase 4 trial found that ocrelizumab controlled disease activity in Black and Hispanic people with relapsing multiple sclerosis, with consistent safety outcomes.

CHIMES Trial: Ocrelizumab in Black and Hispanic Patients With MS

The phase 4 CHIMES trial evaluated the effectiveness and safety of ocrelizumab in 182 Black and Hispanic people with relapsing multiple sclerosis. At week 48, 50.5% of participants achieved no evidence of disease activity across relapse, disability progression, and MRI outcomes. Serious adverse events occurred in 8.2% of participants, while 2.2% discontinued treatment. The findings support ocrelizumab’s clinical effectiveness and tolerability in these underrepresented populations.

A scoping review of 33 studies identifies research gaps in home mathematics environments and early mathematical development among culturally and linguistically minoritized families.

Home Mathematics Environment Research in Culturally Diverse Families

A scoping review of 33 studies examined how family mathematics-related activities, communication, beliefs, and practices influence early mathematical development in culturally and linguistically minoritized families. The evidence primarily came from the United States, Türkiye, Tanzania, China, and Europe. Findings highlighted limited culturally responsive and multilingual assessment tools, a persistent deficit-focused approach, and insufficient longitudinal and intervention research. The authors proposed inclusive strategies such as home-language assessment, participatory measure development, and community partnerships.

OPHTHALMOLOGY

A study of 9,897 uveal melanoma cases found that lower county-level income was associated with higher odds of primary enucleation but not worse overall survival.

Income and Enucleation Risk in Uveal Melanoma Patients

A retrospective analysis of 9,897 patients with uveal melanoma (UM) diagnosed between 1990 and 2021 investigated the relationship between county-level income, primary ocular treatment, and survival. Patients from lower-income counties had 66% higher adjusted odds of undergoing primary enucleation than those from higher-income counties. However, county-level income was not associated with overall survival. The findings highlight socioeconomic differences in treatment patterns while emphasizing the limitations of area-level income measures.

GASTROENTEROLOGY

A systematic review found that lower ultrasound-derived muscle measurements were associated with higher mortality in cirrhosis, highlighting the need for standardization.

Bedside Ultrasound for Sarcopenia and Mortality Risk in Cirrhosis

A systematic review of six prospective studies involving 731 adults with cirrhosis found a consistent association between lower ultrasound-derived skeletal muscle measurements and increased mortality. Ultrasound-defined sarcopenia was associated with higher 6-month mortality among hospitalized patients with decompensated cirrhosis. However, differences in assessment protocols, muscle sites, and sarcopenia definitions prevented pooled analysis. Standardization and further validation are required before routine clinical use.

The FDA’s latest draft gu...

The FDA’s latest draft guidance on accelerated approvals — one step forward, two steps back?