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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The JAK1 inhibitor in development for treating nonsegmental vitiligo was superior to placebo on investigator ratings in two phase 3 trials.

Roflumilast Promising for AD in Children Down to Age 3 Mos

Global assessment and itch/scratch scores highlight the effectiveness of topical roflumilast for treating atopic dermatitis in children 3 months to 2 years old, in a phase 2 study.

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Adrenal crisis remains rare but life-threatening. Better patient, family, and clinician education could help prevent deaths.

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Augmentation of data-based risk models with psychosocial factors obtained from clinical notes may improve the prediction of suicide attempts in patients with suicidal ideation, a study shows.

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South Carolina could declare its ongoing measles ⁠outbreak over by April 26 if no additional infections are reported, the state's ⁠top epidemiologist said during a briefing...

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Patients with non-squamous non-small cell cancer may achieve similar outcomes with a subcutaneous formulation of the immunotherapy toripalimab as with IV administration.

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Can MRI Curb Chemo Overtreatment in Breast Cancer?

MRI offers the possibility of personalized neoadjuvant chemotherapy for patients with HER2-positive breast cancer, but it may not be ready for prime time.

Subcutaneous Toripalimab Matches IV Formulation in NSCLC

Patients with non-squamous non-small cell cancer may achieve similar outcomes with a subcutaneous formulation of the immunotherapy toripalimab as with IV administration.

New Gene Therapy Nears EU Nod for Bladder Cancer

Conditional approval of intravesical gene therapy was supported by clinical evidence showing a 53.4% complete response rate in patients with treatment-resistant non-muscle-invasive bladder cancer.

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The JAK1 inhibitor in development for treating nonsegmental vitiligo was superior to placebo on investigator ratings in two phase 3 trials.

Global assessment and itch/scratch scores highlight the effectiveness of topical roflumilast for treating atopic dermatitis in children 3 months to 2 years old, in a phase 2 study.

Adrenal crisis remains rare but life-threatening. Better patient, family, and clinician education could help prevent deaths.

Augmentation of data-based risk models with psychosocial factors obtained from clinical notes may improve the prediction of suicide attempts in patients with suicidal ideation, a study shows.

Early aortic valve replacement in aortic stenosis, left atrial appendage occlusion in JAMA Cardiology, and a big preview of the upcoming American College of Cardiology meeting are the topics John Mandrola, MD, discusses in this week’s podcast.

South Carolina could declare its ongoing measles ⁠outbreak over by April 26 if no additional infections are reported, the state's ⁠top epidemiologist said during a briefing...

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Childhood AD Not Tied to Cardiovascular Risk in Adulthood

Atopic dermatitis in childhood is not associated with increased early markers of cardiovascular risk, a study finds.

Sick-Day Rules: Preventing Acute Kidney Injury

This practical review explains when to stop ACEI, diuretics, SGLT2 inhibitors, metformin, and NSAIDs during dehydration — how to safely reinstate therapy.

Alpha-Gal Syndrome: For This Doctor, It’s Personal

After two decades tracking cases of the meat allergy, Tina Merritt, MD, urges greater awareness of cross-reactivity and gaps in labeling for mammalian-derived ingredients.

Young Canadians Lack Crucial Knowledge About HPV

Most young survey respondents perceive their understanding of human papillomavirus to be strong, but they tripped up when asked specific facts about the virus.

Infection Risk Surges Around Cirrhosis Diagnosis

Infection risk is elevated around the time of cirrhosis diagnosis vs years prior, with the elevated risk persisting post-diagnosis; the risk is notably higher in patients with decompensated cirrhosis.

Olmesartan-Induced Sprue Causes Diarrhea in a Woman

Recurrent severe diarrhea with acute kidney injury after drug reinitiation highlights a rare but serious enteropathy linked to antihypertensive therapy.

Victoria Pilots PA Program for Harm Reduction Workers

Harm reduction workers who bring lived experience to harm reduction programs may themselves need support for a substance use disorder.

Adrenaline Fails to Reverse Histamine-Induced Hypotension

Standard intramuscular adrenaline fails to reverse histamine‑induced hypotension in healthy adults, new research shows.

Data Support Ruxolitinib’s Safety for Eczema in Children

A long-term analysis offers reassurance to users of the topical treatment recently approved for children down to age 2.

Time to Rethink Early Morning In-Hospital Blood Draws?

Delaying in-hospital blood draws by just 2 hours helped sleep quality and quantity, researchers find. Now, some hospitals are considering a change to traditional timing.

Liver Enzyme Guides Prognosis in CKD Patients on Dialysis

Among patients with CKD, serum total ALP and its liver, bone, and intestinal fractions increase with disease severity, and liver ALP is associated with mortality in those undergoing haemodialysis.

Medical Accuracy of 'The Pitt'

The cast and creators of HBO Max's 'The Pitt' explain how they get the medicine right, and why it matters.

‘I HATE YOU’ and Other Things People Say to Their Doctors

Patient rudeness, in-person or on the portal, is more common than ever, and data now show it’s taking a toll on quality care.

COVID Shots in Pregnancy Protect Infants’ First 6 Months

The research adds important evidence for clinicians counseling pregnant patients.

Barzolvolimab Shows Persistent Benefits for CSU

Patients maintain their improvements off treatment, even after clearance of barzolvolimab, investigators report.

Specialty Care in Crisis in British Columbia

Long wait times for an appointment with a specialist and for treatment after the referral are putting lives at risk, experts say.

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