Practical Information for Today's Pediatrician
Joined January 2023
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๐ In a feasibility study of adolescents with chronic rhinitis, acoustic resonance therapy reduced nasal congestion by 35.2% and improved overall symptoms by 40.5%, with no adverse events reported.
Read our Q&A with SoundHealth CEO Paramesh Gopi, PhD: hubs.ly/Q04lD9Nk0
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๐จThe FDA has granted Orphan Drug Designation to para-chloro-phenylalanine (pCPA), a serotonin synthesis inhibitor being explored as a potential therapy for MAOA deficiency and combined MAO-A/B deficiency.
Read the full story: hubs.li/Q04lBVT70
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At #ENDO2026, investigators reported 6-month interim phase 2 data showing that setmelanotide was associated with reductions in BMI, fat mass, hyperphagia scores, and anxiety-related behaviors in patients aged 6 to 23 years with PWS.
๐ hubs.li/Q04lCKW20
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The FDA issued a Warning Letter today to Happiest Baby, maker of the SNOO Smart Sleeper bassinet, citing multiple violations with direct implications for clinical practice.
๐ Full article: hubs.ly/Q04ltPxs0
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โ ๏ธ RECALL ALERT โ ๏ธ
Nara Organics Whole Milk Organic Powdered Infant Formula has been recalled following a multistate outbreak of infant botulism affecting babies in California, Pennsylvania, and Washington. All 3 infants were hospitalized.
hubs.li/Q04lrVJ60
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๐จThe FDA has approved teplizumab (Tzield) to delay the loss of endogenous insulin production in children and adolescents aged 8 to 17 years recently diagnosed with Stage 3 type 1 diabetes.
hubs.li/Q04lrHB00
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Researchers at CHOP have identified a high-risk immune endotype in children with multiple organ dysfunction syndrome (MODS), with or without sepsis.
Read the full story: hubs.li/Q04lg4Z80
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๐ฑ New Surgeon General advisory: Excessive screen use may affect children's development, sleep, mental health, physical health, and academic performance.
Read more: hubs.li/Q04lgtb_0
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New research in JAMA Network Open found that mental health-related diagnoses are being addressed more frequently during primary care visits, with anxiety showing nearly a 300% increase over the past decade.
๐ Read the full story: hubs.li/Q04lfZSz0
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๐จ FDA update: TOFIDENCE (tocilizumab-bavi; @organonllc) has received expanded indications for patients aged 2 years and older with cytokine release syndrome and for hospitalized patients with COVID-19 who require corticosteroids and respiratory support.
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โ๏ธ A major sunscreen milestone: The FDA has added bemotrizinol to the OTC sunscreen monograph, marking the first new active sunscreen ingredient approved in the US in more than 20 years.
Read more: hubs.li/Q04kX0QV0
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๐จ The FDA has accepted @TakedaPharmaโs application for IV vedolizumab in children as young as 2 years with ulcerative colitis or Crohnโs disease.
If approved, it would become the first gut-selective biologic available for pediatric patients with IBD.
hubs.li/Q04kWjGf0
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The FDA has approved lebrikizumab (EBGLYSS; @EliLillyandCo) for Q8W maintenance dosing in moderate-to-severe atopic dermatitis, as few as 6 injections/year, no required topicals.
Approval based on exposure-response modeling ADjoin extension data.
hubs.li/Q04kLGSJ0
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A research letter recently published in JAMA Pediatrics provides timely quasi-experimental evidence that the influenza vaccine reduces clinically meaningful infections in children aged 2 to 5 years across multiple seasons.
More: hubs.li/Q04kLPZm0
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The FDA has granted orphan drug designation and rare pediatric disease designation to GEn-1123, an investigational oral small-molecule therapy being developed by GEn1E Lifesciences for Duchenne muscular dystrophy (DMD).
Read more: hubs.li/Q04kLGyx0
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New in JAMA Pediatrics: After Australia updated guidelines to recommend egg introduction by 6 months, egg allergy in 1-year-olds dropped ~18%.
The biggest benefit? Infants with early eczema saw allergy rates fall from 34.6% โ 21.9%.
Read more: hubs.li/Q04kzBxl0
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๐จThe @US_FDA has expanded approval of marstacimab (HYMPAVZI; @pfizer) to patients aged 6 years and older with hemophilia A or B, with or without inhibitors, offering a once-weekly subcutaneous prophylactic option.
Read the full coverage: hubs.li/Q04ksnJX0
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Jamie Wood, MD, discusses the FDA approval of Afrezza for pediatric patients and why expanding treatment options matters for children and families living with diabetes.
Read more: hubs.li/Q04kcmxx0
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Our Top 5 Headlines of May included a landmark FDA approval for the first rapid-acting inhaled insulin, new evidence reaffirming HPV vaccine safety, updated AAP drowning prevention guidance, and a global effort to rename PCOS to PMOS.
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The FDA has expanded approval of linaclotide (LINZESS) to children aged 2-5 years with functional constipation, making it the only FDA-approved prescription therapy for pediatric FC in this age group.
Read more: hubs.li/Q04jYTSz0
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