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 treatment landscape for IgA nephropathy is rapidly evolving, with therapies focused on mitigating the effects of nephron loss now being combined with immunomodulatory treatments.

Tolvaptan vs Fluid Limits: Do Costs Outweigh pNa Gains?

Although tolvaptan bests fluid restriction at raising plasma sodium concentration, 19% of patients experience overcorrection of sodium increases.

Outpatient RSV in Kids Younger Than 2 Has Distinct Features

In outpatient care, RSV infections in children younger than 2 years present with distinct clinical features and greater illness burden than infections caused by other respiratory viruses.

Pfizer's Eczema Drug Meets Main Goal in Mid-stage Trial, Plans Late-stage Study

U.S. drugmaker Pfizer said on Monday its experimental drug for a ⁠chronic skin disease met the main goal in a mid-stage study.

Gene Therapy Injections for Knee OA: Where Are We At?

Developers of gene therapies to treat knee osteoarthritis are taking the familiar intra-articular route to deliver proteins and molecules directly to the site of the disease.

Women at Higher Risk for Chronic Cough With Age

Experts report that a chronic cough lasting at least 8 weeks disproportionately affects women, with prevalence increasing with age.

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Have the Harms of Lung Cancer Screening Been Exaggerated?

Three medical societies claim recent studies have overestimated the potential harms from lung cancer screening and may be deterring patients. Not everyone agrees.

Pretreatment Liver Tests Often Overlooked in CDK4/6 Therapy

Despite FDA package insert recommendations, most patients with breast cancer who are prescribed CDK4/6 inhibitors do not receive liver function tests before starting treatment.

Alternative Medicine for Breast Cancer: Study Raises Concern

Patients who receive both standard medical treatment and complementary and alternative therapies have higher mortality — possibly due to reduced use of endocrine therapy and radiation.

Todays Updates

Have the Harms of Lung Cancer Screening Been Exaggerated?

Three medical societies claim recent studies have overestimated the potential harms from lung cancer screening and may be deterring patients. Not everyone agrees.

Pretreatment Liver Tests Often Overlooked in CDK4/6 Therapy

Despite FDA package insert recommendations, most patients with breast cancer who are prescribed CDK4/6 inhibitors do not receive liver function tests before starting treatment.

Alternative Medicine for Breast Cancer: Study Raises Concern

Patients who receive both standard medical treatment and complementary and alternative therapies have higher mortality — possibly due to reduced use of endocrine therapy and radiation.

Latest News

The treatment landscape for IgA nephropathy is rapidly evolving, with therapies focused on mitigating the effects of nephron loss now being combined with immunomodulatory treatments.

Although tolvaptan bests fluid restriction at raising plasma sodium concentration, 19% of patients experience overcorrection of sodium increases.

In outpatient care, RSV infections in children younger than 2 years present with distinct clinical features and greater illness burden than infections caused by other respiratory viruses.

U.S. drugmaker Pfizer said on Monday its experimental drug for a ⁠chronic skin disease met the main goal in a mid-stage study.

Developers of gene therapies to treat knee osteoarthritis are taking the familiar intra-articular route to deliver proteins and molecules directly to the site of the disease.

Experts report that a chronic cough lasting at least 8 weeks disproportionately affects women, with prevalence increasing with age.

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New Model Predicts In-Hospital Death in Acute Liver Failure

A new machine learning model built using a simple and interpretable approach predicts in-hospital death in patients with acute liver failure and reveals top risk drivers.

Verekitug Improved Chronic Rhinosinusitis With Nasal Polyps

Adverse events were similar between the groups, with more high-grade events occurring in the placebo group.

Rituximab Cuts ANCA Vasculitis Pneumococcal Vaccine Response

‘These data indicate that either alternative vaccine strategies or alternative strategies to protect these patients from pneumococcal disease are required,’ said Michael Chen-Xu, MD.

Can We Predict Relapse, Drug Response in Renal Vasculitis?

Patients with a particular histopathologic phenotype may respond less well to rituximab, but it is still unclear what factors best predict relapse in patients with the kidney disease.

Chronic Rhinosinusitis Tied to Increased Cancer Risk

Results from Asia suggest chronic rhinosinusitis is associated with an increased risk for cancer, but whether these results apply to the US population remains uncertain.

New Hereditary Angioedema Drug Navenibart Safe, Effective

Unlike current treatments on the market for hereditary angioedema, navenibart requires dosing only every 3-6 months.

European Food Safety Authority Flags Cannabidiol Safety Gaps

European Food Safety Authority sets a provisional safe intake for cannabidiol at 0.0275 mg/kg per day, or about 2 mg/d for a 70 kg adult.

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.

Prolonged Amoxicillin Challenge Checks Penicillin Allergy

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

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.

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.

Managing Resistant Hypertension Is Like Playing Chess

Managing resistant hypertension requires looking two moves ahead. Dr Chuck Vega discusses edema, hypokalemia, and the surprising renal benefits of MRAs.

AI Finds Three Predictive Variants for Postoperative Sepsis

A genome-wide AI model prioritizes three genetic variants linked to postoperative sepsis and outlines how preoperative genotyping could support targeted monitoring strategies.

Are Italian Doctors Being Punished for Compassion?

The case of six Italian physicians accused of falsifying detention fitness certificates has ignited debate over science, conscience, and politics.

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