News
FDA Expands Leniolisib Approval to Younger Children with APDS
The FDA approved leniolisib (Joenja) on September 11 for children aged 4 through 11 weighing at least 27 kg with activated…
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Immunotherapy & Clinical Trials
Curated clinical updates, research breakdowns, and expert perspectives focusing on specific pathways of childhood immune development and pathology.
News
Real-World Data Confirms Maternal RSV Vaccine Efficacy for Infants
A new systematic review and meta-analysis published in JAMA Pediatrics confirms what the original pivotal trials hinted at: the…
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Can Fecal Microbiota Transplants Safely Reverse Pediatric Peanut Allergies?
The NIH announcement frames the work as a safety and efficacy signal: peanut-tolerant participants tolerated higher allergen…
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New AAP Guidelines for RSV Immunoprophylaxis in High-Risk Infants and Children
The American Academy of Pediatrics has tightened its clinical guidance on RSV immunoprophylaxis, expanding the qualifying…
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How NCI-Backed Rare Disease Research Shapes Pediatric Treatment Strategies
As the National Cancer Institute reports in a recent feature on benefits of NCI-supported rare disease research, one high-grade…
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New ACR Initiative Aims to Improve Early Detection of Pediatric Rheumatic Conditions
According to the American College of Rheumatology (ACR), its 2026 Rheumatic Disease Awareness Month campaign, “Little Joints, Big…
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Ustekinumab Gains FDA Approval for Pediatric Ulcerative Colitis Treatment
The FDA approved ustekinumab (Stelara) on August 28 for moderately to severely active ulcerative colitis in pediatric patients…
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Why the Pediatric Dermatology Shortage Threatens Early Diagnosis of Immune Disorders
According to Medscape, the specialty of pediatric dermatology is being positioned as "a rewarding career path in a critical time…
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Nipocalimab Approval Marks New Era for Treating Warm Autoimmune Hemolytic Anemia
The FDA has approved Imaavy (nipocalimab-aahu) for warm autoimmune hemolytic anemia in adults and adolescents aged 12 years and…
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Predicting Peanut Allergy Desensitization Success Through Baseline Immune Profiling
A study surfaced on ResearchGate this week — published in Allergy, Asthma & Clinical Immunology — that addresses a question I…
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New FDA Procedures for Pediatric Biologics Research Under PREA and BPCA
The FDA's Center for Biologics Evaluation and Research has released Version 3 of its standard operating procedure for applying…
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Can Daily Zinc Supplements Lower Infection Rates in Children With Sickle Cell Anemia?
According to Medical Dialogues' coverage of the ZIPS-2 randomized clinical trial published in JAMA, daily 20-mg oral zinc sulfate…
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Severe Eczema Linked to Stunted Growth in Children: New Clinical Findings
A new peer-reviewed study from Trinity College Dublin, published in the Journal of the American Academy of Dermatology, reports…
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Boosting CAR T-Cell Potency Against Pediatric Osteosarcoma by Deleting Regnase-1
Researchers at St. Jude Children's Research Hospital report that deleting the Regnase-1 gene from B7-H3-targeted CAR T cells…
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Mastering Diagnostic Patterns for Inborn Errors of Immunity in Pediatric Practice
A structured expert-elicitation study distributed through JoVE Visualize and Pediatric Allergy and Immunology has done something…
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Canada’s First Paediatric Olink Lab Aims to Transform Precision Diagnostics for Children
According to a recent announcement from Children's Health Research Institute (CHRI), researchers at London Health Sciences Centre…
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Why Clinical Expertise Is the Deciding Factor in Pediatric Ig Infusion Success
A longitudinal study of 1,736 intravenous immunoglobulin infusions in 70 pediatric patients with inborn errors of immunity…
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HHS Reviewing Vaccine Recommendation Framework and Shared Clinical Decision-Making
Announced by the Department of Health and Human Services on August 21, the RFI signals an evaluation of how recommendations are…
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New Orphan Drug Designation for Artemis-Deficient SCID Gene Therapy
The European Medicines Agency has issued a positive opinion on an orphan designation for an autologous CD34+ stem cell gene…
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Scaling Rapid Whole-Genome Sequencing for Critically Ill Pediatric Patients
The Nature study frames citywide rapid WGS implementation as a system-level intervention rather than a single-center pilot, which…
Immunotherapy & Clinical Trials
Home SCIG Therapy: Pre-Start Checklist for Families
The data supporting home subcutaneous immunoglobulin therapy in pediatric primary immunodeficiency is no longer in dispute…
Immunotherapy & Clinical Trials
Pediatric Clinical Trial Travel: Hidden Cost Pitfalls
When we discuss the barriers to pediatric clinical trial enrollment, the conversation often centers on eligibility criteria or…
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How T Cells Use Mechanical Cues to Build Long-Term Immunity
According to McGill University Health e-News, a McGill-led study has found that T cells can sense the stiffness of the tissue…
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Broadening the Clinical Understanding of SIFD Through Novel TRNT1 Genetic Variants
A new case report published in Frontiers in Immunology describes a pediatric patient carrying a previously unreported c.841G>C…
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New London Pediatric Lab Uses Proteomics to Predict Disease Before Symptoms Emerge
The Children's Health Research Institute in London, Ontario, has opened what it claims is Canada's first pediatric laboratory…
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FDA Grants Accelerated Approval for First Gene Therapy Treating GSDIa in Children and Adults
The FDA has cleared the first gene therapy for Glycogen Storage Disease Type Ia (GSDIa), approving Genglycos (pariglasgene…
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Evaluating the New Benchmark in Pediatric Clinical Research Methodology
Medical Xpress is flagging a recent study that, in its framing, sets a new standard for pediatric research — and that framing…
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Mapping Immune Dysregulation in Pediatric Dengue via Bulk Transcriptomics
According to a study indexed on PubMed, researchers applied bulk transcriptomics to peripheral blood mononuclear cells from…
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In Vivo Base Editing for Neonatal Metabolic Disorders: Clinical Reality vs. Roadmap
Per a recent Cureus review, the field of in vivo base editing for neonatal inborn errors of metabolism has moved from bench…
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Predicting Long-Term Peanut Tolerance: Insights from the OPIA Trial Biomarkers
According to a PubMed-indexed analysis of the OPIA trial, baseline functional profiles of peanut-reactive T cells may serve as…
Immunotherapy & Clinical Trials
Immunoglobulin dose: does infection require a temporary boost?
In my experience running pediatric immunodeficiency cohorts, this is the single most common dosing question I get from both…
Immunotherapy & Clinical Trials
Pediatric gene therapy trials: the enrollment roadmap
For families considering a pediatric gene therapy clinical trial, the most difficult part is often not finding a study. It is…
Immunotherapy & Clinical Trials
Expanded access vs clinical trials for pediatric patients
The FDA reports an approval rate of approximately 99% for submitted Expanded Access Program applications, with more than 75%…
Immunotherapy & Clinical Trials
Pediatric stem cell transplant: pre-admission checklist
A pediatric hematopoietic stem cell transplant (HSCT) rarely begins on the day the cells are infused. By the time the product…
Immunotherapy & Clinical Trials
Pediatric biologic therapy: avoiding insurance denial traps
A denial of pediatric biologic therapy is rarely a simple statement that a child is “not eligible” for treatment. More often, it…
Immunotherapy & Clinical Trials
IVIG vs SCIG: choosing a pediatric infusion route
Intravenous and subcutaneous immunoglobulin replacement constitute the two established administration routes for pediatric…
Immunotherapy & Clinical Trials
Can kids on immunoglobulin therapy get live vaccines?
The deferral question lands on my desk roughly once a week. A family has a child on monthly IVIG for a primary antibody…
Immunotherapy & Clinical Trials
Pediatric CAR-T Cell Therapy Pre-Treatment Checklist
The 2017 FDA approval of tisagenlecleucel for pediatric and young adult relapsed/refractory B-cell ALL was supposed to be the…
News
The Funding Gap Threatening the Future of Pediatric Medical Research
The Forbes piece, dated August 11, landed alongside a cluster of practical pediatric guidance updates that underscore exactly why…
Immunotherapy & Clinical Trials
Parent Checklist for Pediatric Clinical Trial Enrollment
In July 2026, the BMJ published the SPIRIT-C 2026 and CONSORT-C 2026 extensions — a set of new reporting expectations intended to…