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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Conditional EU Nod for Weekly Pill in Pediatric Glioma

Current treatment options include surgery and chemotherapy, but chemotherapy’s benefits are often modest and can cause substantial side effects.

Latest News

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

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 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 surged to 979 on Tuesday, state health data ⁠showed, including six additional infections since Friday.

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

Despite increased STI testing in US emergency departments from 2020 to 2024, syphilis screening is often missed, particularly among female and insured patients.

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NIH Denies Renewal of NIAMS Director’s Contract

Criswell will reportedly stay on as an intramural scientist, continuing to investigate genetic causes of autoimmune diseases.

Omalizumab Appears Superior to Dupilumab in Urticaria

Omalizumab shows superior efficacy to dupilumab in reducing symptoms in patients with chronic spontaneous urticaria.

Brief Program Improves QoL in Patients With Severe Allergies

Small gains in self-efficacy and injectable epinephrine prescription use were measured.

Flu Shot May Boost Survival in Patients With Cancer on ICIs

Patients with advanced cancer receiving influenza vaccination during immunotherapy had longer survival in a Swedish study, with no increase in immune-related toxicities.

Measles Cases in South Carolina Rise by 11 to 973

Measles cases in South Carolina surged to 973 on Friday, state ⁠health data showed, including 11 additional infections since Tuesday.

Going Home: Discharge Tips for CMC Patients

The number of children with medical complexity is growing and an efficient discharge requires a team approach. Here is how to make the transition successful.

Novel Combination Therapy: Breakthrough in Brain Metastases?

The combination of stereotactic RT or radiosurgery with immunotherapy or targeted therapy shows manageable toxicity and improved local control and clinical benefit in patients with brain metastases.

Pediatric Rheum Survey Shows Need to Improve Vaccine Reviews

A consensus statement with more specific guidance on communication practices may help standardize approaches to vaccine-related communication with families, author says.

Epinephrine Nasal Spray Promising for Urticaria Flares

In a phase 2 trial, patients having an urticaria exacerbation who used the spray report better hive and pruritus scores than the placebo group.

What’s at Issue in the FDA’s Request to Withdraw Avacopan?

European regulators are also conducting a review of avacopan. The issue appears to involve data from the pivotal ADVOCATE trial and questions of liver safety.

RSV Hits Harder in Kids With Asthma

Tests of tissue models show faster spread of virus in children with asthma than in nonasthma control participants.

Patient Preferences Drive Treatment for Allergic Rhinitis

Patients with pollen-related allergic rhinitis prefer on demand antihistamines, with treatment preferences differing markedly by age group, new research finds.

Early Top-Down Therapy May Modify Course of Crohn’s Disease

Starting biologic therapy at diagnosis, rather than escalating later, may significantly reduce complications and hospitalizations in Crohn’s disease, according to new data.

FDA Approves New Topical for Atopic Dermatitis

Difamilast is the third PDE4 inhibitor approved by the FDA for treating atopic dermatitis.

Gluten Sensitivity Without Celiac Disease Common in IBS

About 30% of young adults with irritable bowel syndrome report gluten sensitivity without celiac disease or wheat allergy and improve on a gluten-free diet.

HER2 Therapy for Biliary Cancer Approved by UK Regulator

The MHRA approved a first-in-class bispecific antibody for HER2-positive biliary tract cancer, offering a new line of therapy for patients who have progressed on standard care.

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