FDA review of dupilumab for chronic spontaneous urticaria

Published Date: 13 Mar 2023

The FDA approval request for CSU is based on data from a pair of Phase 3 trials in two different populations.

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Systemic Onychomycosis Rxs: Hepatoxicity Risks Compared

Terbinafine shows lower risk for hepatotoxicity than other systemic antifungal treatments in patients with onychomycosis and chronic liver disease.

Replimune's Drug for Advanced Skin Cancer Fails to Win FDA Nod Again

The U.S. Food and Drug Administration on Friday declined to approve Replimune's drug ⁠for advanced skin cancer, citing insufficient data from studies, sending its shares...

Most US Infants Have an Enteric Viral Infection by Age 2

Norovirus GII and sapovirus were the most common pathogens and would be targets for vaccines.

Conference MDAngle: AAN 2026 Myasthenia Gravis

Insights from AAN 2026, including anticipated presentations, key takeaways, and how emerging research in myasthenia gravis may affect patient care.

Neuroimmunome Predicts Viral Hepatitis Severity

A neuroimmune gene signature detectable in blood and liver predicts viral hepatitis severity, suggesting nervous-immune crosstalk drives disease progression and informs monitoring.

Potato Allergy in Children: New Data

Potato allergies tend to appear in infancy, often with skin symptoms, and may be triggered by the vegetable when it is cooked or raw, according to a Turkish study.

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Low Income, Education Tied to Depression in Older Adults

Older adults with chronic disease who have less education, lower income, and no active jobs tend to experience symptoms of depression.

Infection Burden High With Myeloma T-Cell Therapies

A retrospective study suggests a high burden of prolonged, mostly low-grade infections in patients with multiple myeloma who receive T-cell-engaging therapies.

Weight-Based and Fixed-Dose Pembrolizumab Compared in NSCLC

A national cohort study compares the safety and efficacy of weight-based and fixed-dose pembrolizumab regimens in patients with advanced non-small cell lung cancer.

HER2 ADC Shows Promise in Recurrent Endometrial Cancer

Trastuzumab pamirtecan, a HER2-targeted antibody-drug conjugate, achieved ‘exceptional’ antitumor responses in patients with recurrent endometrial cancer, especially those with HER2 IHC 3+ tumors.

Todays Updates

Low Income, Education Tied to Depression in Older Adults

Older adults with chronic disease who have less education, lower income, and no active jobs tend to experience symptoms of depression.

Infection Burden High With Myeloma T-Cell Therapies

A retrospective study suggests a high burden of prolonged, mostly low-grade infections in patients with multiple myeloma who receive T-cell-engaging therapies.

Weight-Based and Fixed-Dose Pembrolizumab Compared in NSCLC

A national cohort study compares the safety and efficacy of weight-based and fixed-dose pembrolizumab regimens in patients with advanced non-small cell lung cancer.

HER2 ADC Shows Promise in Recurrent Endometrial Cancer

Trastuzumab pamirtecan, a HER2-targeted antibody-drug conjugate, achieved ‘exceptional’ antitumor responses in patients with recurrent endometrial cancer, especially those with HER2 IHC 3+ tumors.

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Terbinafine shows lower risk for hepatotoxicity than other systemic antifungal treatments in patients with onychomycosis and chronic liver disease.

The U.S. Food and Drug Administration on Friday declined to approve Replimune's drug ⁠for advanced skin cancer, citing insufficient data from studies, sending its shares...

Norovirus GII and sapovirus were the most common pathogens and would be targets for vaccines.

Insights from AAN 2026, including anticipated presentations, key takeaways, and how emerging research in myasthenia gravis may affect patient care.

A neuroimmune gene signature detectable in blood and liver predicts viral hepatitis severity, suggesting nervous-immune crosstalk drives disease progression and informs monitoring.

Potato allergies tend to appear in infancy, often with skin symptoms, and may be triggered by the vegetable when it is cooked or raw, according to a Turkish study.

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Early Oral Antibiotics: A Safe Shift in Bone Infections

Early switching from intravenous to oral treatment does not compromise treatment success in children with bone and joint infections and may reduce the risk for complications.

AD Not Linked to Poor Academic Performance in Adolescents

Atopic dermatitis does not significantly impair academic performance, a study finds.

High-Flow Oxygen Slightly Reduces Intubation, Not Mortality

High-flow nasal oxygen appears to reduce intubation incidence but does not reduce mortality in ICU patients with acute hypoxemic respiratory failure.

Sunscreen Use Has Doubled Among Black Individuals

The rate at which individuals with darker skin tones take steps to protect themselves from the sun has doubled in 20 years, but there is a great distance to go.

Dermatologist’s Guide to Patients With Personality Disorders

Reassurance, routine, and respect are key to navigating difficult encounters.

Biomarkers Track AD Severity in Children

Serum thymus and activation-regulated chemokine and squamous cell carcinoma antigen 2 are superior to total IgE or eosinophils in assessing atopic dermatitis severity, a retrospective study finds.

Treating IgG4-RD: How Far Will B-Cell Drugs Take the Field?

Post hoc analyses of pivotal MITIGATE trial show broad efficacy across patient subgroups with differing organ involvement and clinical characteristics.

Growth in Sector, Private Equity Fuel Hospitalist Lawsuits

Malpractice claims against hospitalists highest of any specialty.

Predicting Early Death in Immunocompromised Status With ARF

In immunocompromised patients with acute hypoxemic respiratory failure, frailty and longer hospital-to-ICU time may raise 30-day mortality, whereas high-flow nasal oxygen is protective.

Autoimmune Disease in Parent Tied to Allergy Risk in Child

Having a parent with an autoimmune disease may be associated with an increased risk for allergic diseases, a meta-analysis shows.

GLP-1 Drugs Under Scrutiny: How Real Are the Risks?

Gastrointestinal adverse effects remain a key barrier to continued use of these agents, with slower dose titration emerging as a strategy to improve tolerability and adherence.

Early Warning Scores Fairly Accurate in Older Adults in ED

Early warning scores fairly predict 24-h deterioration in adults aged 80 years or older in the emergency department, with the Rapid Emergency Medicine Score more consistent and improving with age.

Mediterranean Diet Linked to Lower Adult-Onset Asthma Risk

Clinicians can reasonably include Mediterranean-style eating in respiratory prevention counseling — alongside smoking cessation, exercise, weight control, and exposure reduction.

Abrocitinib Effective for Hand Eczema in Phase 2 Study

In the phase 2 trial, efficacy was also seen in patients with non-atopic chronic hand eczema treated with the oral JAK inhibitor.

Ciprofloxacin for Transplant Prophylaxis: Time to Rethink?

In allogeneic haematopoietic cell transplant recipients, ciprofloxacin prophylaxis may reduce bloodstream infections but is tied to higher rates of antimicrobial resistance and antibiotic use.

Docs, Lawsuit Challenge Medicare WISeR Prior Auth Experiment

Doctors in multiple states report unpaid claims and care delays under the new federal program, as a lawsuit seeks answers about AI algorithms and data security.

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