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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Mild Brain Injury Frequently Missed in the ED

Only 21% of adults with closed head injury have mTBI diagnosed or clinically suspected in the ED, despite 41% meeting diagnostic criteria, with missed diagnoses most common among middle-aged adults.

A Rare Hearing Implant Bypasses Damaged Nerves

When cochlear implants failed, doctors turned to a brainstem auditory implant to restore sound awareness in a patient with profound deafness.

D10 Matches D50 for Hypoglycemia, Shows Lower Rebound Risk

A lower-concentration dextrose solution matches the standard treatment for hypoglycemia in the emergency department but carries a lower risk for rebound hypoglycemia.

Two-Midnight Rule: Key Strategies for Observation Patients

The Two-Midnight Rule has created important clinical and operational strategies for hospitals.

AAD Issues Guidelines on Treatment-Refractory Adult Eczema

Experts suggest a more ‘whole person’ differential diagnosis when adults do not respond to atopic dermatitis treatment.

Pediatric Atopic Dermatitis: Biologic Revolution Continues

The pediatric atopic dermatitis treatment landscape expands as new biologics emerge, and researchers ask whether earlier intervention can change the course of disease.

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Osimertinib's OS Benefit in Resected NSCLC Persists 8 Years

Even years after treatment ends, adjuvant osimertinib brings an overall survival benefit to patients with resected EGFR-mutated lung cancer.

Pelvic RT Tied to Longer Survival in Cervical Cancer

In patients with newly diagnosed stage IVB cervical cancer, adding definitive-dose pelvic radiotherapy to chemotherapy was associated with longer survival compared with chemotherapy alone.

New Data Put ADCs on the Map in Relapsed SCLC

Two B7-H3-directed antibody-drug conjugates substantially improve survival over topotecan among patients with relapsed small cell lung cancer — pointing to a potential new treatment class.

Real-World Liso-Cel Results in MCL Consistent With Trials

Two analyses of liso-cel CAR T-cell therapy in relapsed or refractory mantle cell lymphoma show response rates in the real-world setting similar to those seen in clinical trial populations.

Antibiotic Use in Hospice Linked to Higher Mortality Risk

Antibiotic use in patients under hospice care is associated with an increased risk for mortality; for infectious hospice-qualifying conditions, antibiotic use is linked to extended survival.

Todays Updates

Osimertinib's OS Benefit in Resected NSCLC Persists 8 Years

Even years after treatment ends, adjuvant osimertinib brings an overall survival benefit to patients with resected EGFR-mutated lung cancer.

Pelvic RT Tied to Longer Survival in Cervical Cancer

In patients with newly diagnosed stage IVB cervical cancer, adding definitive-dose pelvic radiotherapy to chemotherapy was associated with longer survival compared with chemotherapy alone.

New Data Put ADCs on the Map in Relapsed SCLC

Two B7-H3-directed antibody-drug conjugates substantially improve survival over topotecan among patients with relapsed small cell lung cancer — pointing to a potential new treatment class.

Real-World Liso-Cel Results in MCL Consistent With Trials

Two analyses of liso-cel CAR T-cell therapy in relapsed or refractory mantle cell lymphoma show response rates in the real-world setting similar to those seen in clinical trial populations.

Antibiotic Use in Hospice Linked to Higher Mortality Risk

Antibiotic use in patients under hospice care is associated with an increased risk for mortality; for infectious hospice-qualifying conditions, antibiotic use is linked to extended survival.

Latest News

Only 21% of adults with closed head injury have mTBI diagnosed or clinically suspected in the ED, despite 41% meeting diagnostic criteria, with missed diagnoses most common among middle-aged adults.

When cochlear implants failed, doctors turned to a brainstem auditory implant to restore sound awareness in a patient with profound deafness.

A lower-concentration dextrose solution matches the standard treatment for hypoglycemia in the emergency department but carries a lower risk for rebound hypoglycemia.

The Two-Midnight Rule has created important clinical and operational strategies for hospitals.

Experts suggest a more ‘whole person’ differential diagnosis when adults do not respond to atopic dermatitis treatment.

The pediatric atopic dermatitis treatment landscape expands as new biologics emerge, and researchers ask whether earlier intervention can change the course of disease.

News All Time

Alopecia Areata Consensus Statement Recommends First-Line Rx

An expert consensus panel has offered the first-ever standardized, evidence-based recommendations for the management of alopecia areata, identifying JAK inhibitors as the first-line therapy.

Mycobacteria Linked to Worse Lung Transplant Outcomes

In lung transplant recipients, detecting nontuberculous mycobacteria in the first year after a transplant may signal heightened risks for death or a repeat transplant and for chronic graft decline.

Fluticasone Improves Sinusitis Across Disease Profiles

Fluticasone delivered via an exhalation system reduces symptoms and improves quality of life in adults with chronic rhinosinusitis, across inflammatory endotypes and comorbidities, a study shows.

VTE Rare in Burn Patients on LMWH Prophylaxis

A 12-year study of patients hospitalized for burns receiving pharmacologic prophylaxis finds that venous thromboembolism occurs in < 2% of patients overall.

Stem Cells Improve Sight — and Open New Possibilities

People with a progressive genetic eye disorder see more clearly after receiving engineered grafts that repair the damaged surfaces of their eyes, offering a glimpse at what future treatments could hold.

Fall Allergy Season Becoming a Moving Target

An early pollen season means earlier onset of allergy symptoms and earlier patient visits for relief.

Early MRI Detects Brain Injury in Newborns With HIE

MRI performed during therapeutic hypothermia accurately identifies the pattern and severity of brain injury in newborns with hypoxic-ischemic encephalopathy.

Syncope or Fall? A Practical Risk Approach in Older Adults

Experts say witness accounts, ECG findings, and simple risk scores can help clinicians distinguish syncope from a mechanical fall.

Evommune Scraps Eczema Drug After Trial Miss, Shares Plunge

Evommune said on Tuesday it will not advance its experimental skin disease ⁠drug after it failed to meet the main goal in a mid-stage trial, ⁠sending its shares down 24% in...

Sparsentan Achieves Rapid, Sustained Response in Nephropathy

In patients with immunoglobulin A nephropathy treated according to current standards of care, sparsentan use is linked to a rapid and sustained reduction in proteinuria, a real-world study finds.

Does Humor Have a Place in Modern Medicine?

Medical anecdotes show how wit, empathy, and communication can shape clinical encounters, offering a glimpse into human experiences that unfold beyond diagnosis and treatment.

Genetic Testing Before Prescribing: Routine or Selective?

Pharmacogenetic testing can inform medication choice and adverse effect risk, while questions remain about implementation, data storage, and access in routine care.

Memantine May Help Improve Cognition in Patients With SLE

Treatment with memantine may help improve cognitive function in patients with systemic lupus erythematosus and neuropsychological deficits, a phase 2 study finds.

Dupilumab Improves Lung Function in Asthma and ABPA

Dupilumab improves lung function and reduces corticosteroid dependence in patients with asthma and allergic bronchopulmonary aspergillosis compared with placebo, a phase 2 trial finds.

PTCy Shows Promise for Mismatched Donor Transplants

A phase 2 trial evaluates whether posttransplant cyclophosphamide can support the use of mismatched unrelated donor transplants in patients needing reduced-intensity or non-myeloablative conditioning.

When It’s Really Hot: What Mental Health Risks Are Missed?

Extreme heat can worsen psychiatric symptoms and disrupt sleep, whereas some medications may increase vulnerability to dehydration, heat illness, and toxicity.

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