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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Subunit RSV Vaccine Recommended for Adults Older Than 75

The protein subunit vaccines reduced hospitalizations for one season and severe illness for two seasons.

Early Neonatal Infection Linked to Cognitive Risk Later

Early-onset neonatal infection is linked to higher risks for intellectual disability and special educational needs during childhood, with meningitis carrying a higher risk than sepsis.

ELISA Test Fares Best for Identifying ABPA

A small percentage of samples from possible cases meet serologic criteria for infection.

Fix Mold, Reduce Asthma ED Visits?

New York City’s Mold Busters program is associated with thousands fewer emergency department visits for asthma per year, research shows.

Prolonged Amoxicillin Challenge Checks Penicillin Allergy

A 5-day amoxicillin challenge is feasible for evaluating delayed penicillin allergy, a new study shows.

Family History of Kidney Failure Tied to CKD Progression

In patients with chronic kidney disease, a family history of kidney failure may raise the risk for disease progression, even after accounting for individual genetic risk and social factors.

Todays Updates

Should Biology Replace Organ Labels in Cancer Treatment?

A leading oncologist proposes classifying metastatic cancer by molecular alterations rather than organ origin, arguing that the shift could accelerate drug access.

US CDC Deploys Staff to Curb South Carolina's Measles Outbreak

(Refiles to remove extraneous word years from first paragraph)

After FDA Declined Review, EMA Backs 1st Flu-COVID mRNA Vax

The Moderna vaccine will likely be available in Europe long before the US.

Saline Lavage Shows No Clinical Benefit in Pleural Infection

Saline lavage, alone or combined with intrapleural enzyme therapy, confers no clinically meaningful advantage over intrapleural enzyme therapy alone in patients with pleural infection.

Your Patient Doesn’t Like Your Accent or Color: Now What?

Many doctors facing racism from patients stay silent, doubting they’ll be heard. Experts share strategies for handling bias when institutions fall short.

Doravirine Plus Islatravir Matches Standard HIV Therapy

In patients with HIV‑1 infection and virologic suppression, switching to an investigational regimen of doravirine plus islatravir shows efficacy and safety similar to standard ART regimens.

Peak Anti-HBs Level May Predict Protection in HIV Infection

Peak anti-hepatitis B surface antibody levels predicted increased viral protection in HIV, a French study shows.

Todays Updates

Should Biology Replace Organ Labels in Cancer Treatment?

A leading oncologist proposes classifying metastatic cancer by molecular alterations rather than organ origin, arguing that the shift could accelerate drug access.

US CDC Deploys Staff to Curb South Carolina's Measles Outbreak

(Refiles to remove extraneous word years from first paragraph)

After FDA Declined Review, EMA Backs 1st Flu-COVID mRNA Vax

The Moderna vaccine will likely be available in Europe long before the US.

Saline Lavage Shows No Clinical Benefit in Pleural Infection

Saline lavage, alone or combined with intrapleural enzyme therapy, confers no clinically meaningful advantage over intrapleural enzyme therapy alone in patients with pleural infection.

Your Patient Doesn’t Like Your Accent or Color: Now What?

Many doctors facing racism from patients stay silent, doubting they’ll be heard. Experts share strategies for handling bias when institutions fall short.

Doravirine Plus Islatravir Matches Standard HIV Therapy

In patients with HIV‑1 infection and virologic suppression, switching to an investigational regimen of doravirine plus islatravir shows efficacy and safety similar to standard ART regimens.

Peak Anti-HBs Level May Predict Protection in HIV Infection

Peak anti-hepatitis B surface antibody levels predicted increased viral protection in HIV, a French study shows.

Latest News

The protein subunit vaccines reduced hospitalizations for one season and severe illness for two seasons.

Early-onset neonatal infection is linked to higher risks for intellectual disability and special educational needs during childhood, with meningitis carrying a higher risk than sepsis.

A small percentage of samples from possible cases meet serologic criteria for infection.

New York City’s Mold Busters program is associated with thousands fewer emergency department visits for asthma per year, research shows.

A 5-day amoxicillin challenge is feasible for evaluating delayed penicillin allergy, a new study shows.

In patients with chronic kidney disease, a family history of kidney failure may raise the risk for disease progression, even after accounting for individual genetic risk and social factors.

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Severe Skin Symptoms in IgA Vasculitis Linked to Relapse

Children with IgA vasculitis who present with severe skin manifestations may be at higher risk for relapse and should be followed up for at least 1 year.

Alopecia Areata May Raise Risk for Autoimmune Diseases

Patients with new-onset alopecia areata are at increased 10-year risk of developing several immune-mediated inflammatory diseases, according to a study.

Blood Test Widens Door to Early Crohn’s Disease Diagnosis

Heightened immune response to flagellins in commensal gut microbes predicted future CD in healthy first-degree relatives of patients.

Report: 1 in 5 Adults Developed Food Allergies After Age 18

Among other highlights of a new national status report is that only 5200 allergists practice in the US, which translates to 1.6 allergists per 100,000 people.

'Golden Hour' Rarely Achieved in Rural Trauma Care

Patients with trauma in rural areas travel nearly 190 miles and wait over 7 hours for definitive care, far exceeding the 'golden hour', as per a 10-year Montana study.

Vascular Cognitive Impairment and Dementia

This state of the art review describes the clinical features, pathophysiology, and biomarkers of vascular cognitive impairment and dementia for cardiovascular clinicians.

Lymphoma Tx Linked to Mild Photodistributed Skin Reactions

About 1 in 5 patients with B-cell lymphoma treated with loncastuximab develop skin-related adverse events, particularly photodistributed erythematous patches, a study finds.

Impact of Environmental Allergens on Asthma Varies With Age

Older adults may be more vulnerable to asthma, study suggests.

EMA Supports First European Therapy for WHIM Syndrome

WHIM syndrome is an ultra-rare hereditary immunodeficiency disease that leads to recurrent severe infections and an increased risk for viral-associated cancer.

Study Backs Longer Compounded Lido Plus Epi Shelf Life

Research supports the safety and efficacy of compounded lidocaine plus epinephrine for up to 24 hours at room temperature and up to 7 days with refrigeration.

Two New Options for Chronic Spontaneous Urticaria in the EU

EU advisers recommend an oral add-on for adults who remain symptomatic on antihistamines and expanded dupilumab to ages 2-11, bringing the first biologic option to this group.

Secukinumab Doubles Remission Rate in Polymyalgia Rheumatica

The REPLENISH trial finds secukinumab doubles the remission rate and significantly lowers steroid use in relapsing polymyalgia rheumatica.

Store Peanut Products Effective for Desensitization in Kids?

A practical volume-based peanut oral immunotherapy protocol using store-bought peanut powder appears effective and safe for desensitizing children with peanut allergy.

Walk-In Visits Cut Wait Times for Children With AD, HS

Walk-in appointments can reduce the time to pediatric dermatology visits for both atopic dermatitis and hidradenitis suppurativa and reduce ED visits for atopic dermatitis, a study finds.

Measles Cases in South Carolina Rise by 6 to 979

Measles cases in South Carolina surged to 979 on Tuesday, state health data ⁠showed, including six additional infections since Friday.

Severe Infection Linked to Long-term IBD Risk

Severe infections requiring hospitalization are associated with a markedly increased long-term IBD risk, with immune-related genetic variants modifying susceptibility.

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