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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Todays Updates

Timely ‘Nudges’ Help Spur Talks on Patient Care Goals

Simple well-timed prompts to clinicians and patients with advanced cancer can increase conversations around care goals, but clear documentation remains a challenge.

Latest News

A rare biopsy complication turned life-threatening in two 71-year-old patients. One recovered fully; the other was left with lasting paresis after cerebral air embolism.

When physicians grapple with anger, it leaches into every part of the day and saps the best parts of your energy and demeanor. It doesn’t have to be inevitable.

Signs of inflammatory arthritis can be masked by aging, osteoarthritis, and even side effects of medication.

The U.S. Food and Drug Administration approved the first generic ⁠version of Roche's Xofluza, a single-dose flu medicine for certain patients aged ⁠five years and older, the...

The urine albumin-to-creatinine ratio can independently predict the yearly loss of kidney function in patients with Alport syndrome, a German study finds.

Risankizumab is more effective than ustekinumab in achieving sustained clinical improvements in health-related quality of life in patients with Crohn’s disease.

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Adrenaline Underused in Food-Induced Anaphylaxis at Schools

Food-induced anaphylaxis in children in educational settings is commonly triggered by peanuts and is linked to the underuse of adrenaline, a study finds.

Are Difficult Migraine Cases Overtested and Misdiagnosed?

Patients with resistant or refractory migraine undergo repeated diagnostic tests and are often misdiagnosed as having sinus or neck condition.

Remibrutinib Resolves Chronic Inducible Urticaria

Remibrutinib achieves complete response for the three most common subtypes of chronic inducible urticaria in a phase 3 clinical trial.

Dupilumab Outperforms Omalizumab in High-Biomarker Asthma

Patients with asthma and chronic rhinosinusitis with nasal polyps derive greater benefit from dupilumab as eosinophil and fractional exhaled nitric oxide levels increase.

Study Provides Clues to Paroxetine’s Effects in Rosacea

Paroxetine treatment is associated with clinical improvements and distinct proteomic changes in a small study of women with refractory erythematous rosacea.

True Scale Of Congo Ebola Outbreak Still Unknown One Month in, Responders Say

One month after Ebola cases were confirmed in eastern Congo, its true scale remains unknown, with major data gaps muddying the picture and persistent, sometimes violent,...

IRhythm Discloses Cyber Incident, Says no Impact on Device Systems, Patient Safety

iRhythm Holdings on Monday reported unauthorized activity involving data maintained on some third-party applications last ⁠week, but said it has not identified any impact on...

Reducing Readmissions: What Works?

With more hospitals expected to face readmission penalties, hospitals continue efforts to decrease readmissions. Two programs that focus on keeping in touch with patients postdischarge are helping.

When Medicine Gets Too Heavy, Find What Lifts You Up

‘Joy, curiosity, creativity, beauty, passion, and connection.’ These doctors embrace optimistic side gigs as a powerful antidote to the suffering they witness every day.

The Hidden Health Toll of Loneliness in Aging

Loneliness in older adults is more than a social concern — it is linked to higher mortality, poorer mental health, frailty, and faster cognitive decline.

Sound Wave Therapy Improves Kids’ Congestion

High adherence and absence of adverse events support the feasibility of nondrug treatment.

Wearable Diabetes Devices: Triggers Behind Most Dermatitis

A patch-testing study highlights the compounds that account for most of the contact dermatitis from insulin infusion and glucose monitoring devices.

Peanut Allergy Labels Removed in One Third of Infants

Formal food challenges before oral immunotherapy allowed early delabelling of peanut allergy in more than one third of Australian infants despite prior reactions and evidence of sensitization.

Promising Results for Sonelokimab in Early-Phase axSpA Trial

Results of the phase 2, open-label, single-arm S-OLARIS study provide ‘proof of concept’ that the novel IL-17A/F-inhibiting nanobody has an effect on patients with axial spondyloarthritis.

Now We Can Remove Microplastics From the Body: Does It Help?

Researchers used a basic procedure to lower microplastic levels in the body, but no one knows if this benefits the patient or how long until new plastics leach back in.

Nipocalimab Outshines Placebo in Phase 2b Lupus Study

A higher percentage of participants treated with nipocalimab 15 mg/kg met the primary endpoint of an SLE Responder Index-4 composite response at week 24 than placebo.

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