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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Anti-HLA Antibodies Linked to Fetal Growth Restriction

Anti-HLA antibody levels increased with the number of prior pregnancies and decreased with time since the last pregnancy, consistent with pregnancy-related alloimmunization.

JAK Inhibitors Not Tied to CVD Risk in Older Adults With AD

Oral JAKi are not associated with an increased short-term risk for major adverse cardiovascular events or venous thromboembolism in adults aged 50 years or older with atopic dermatitis.

For Doctors, Opt-Out Donation = Tough Family Conversations

Across Europe, presumed consent has not removed families from organ donation decisions — or spared doctors from difficult bedside conversations.

EDTA Lock Solutions: Could Catheter Patency Improve?

A multicenter trial finds that a 4% tetrasodium EDTA lock solution reduces catheter related complications, driven largely by fewer occlusions requiring thrombolysis.

Executive Order on Vaccines Defies Federal Ruling

Any attempt to change the vaccine schedule without proper process and evidence will invite further legal action, say attorney for physician groups.

Asthma Control: How Much ICS Is Enough?

Low-dose ICS remain essential for every asthma patient, and GINA/CFA guidance favors phenotype-tailored step-up strategies rather than routine dose escalation to prevent exacerbations.

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Isatuximab Boosts MRD Negativity in Multiple Myeloma

Researchers compare two different treatment regimens in 446 transplant-ineligible patients with newly diagnosed multiple myeloma in a global phase 3 trial.

Novel ADC Improves Survival in Metastatic TNBC

Izalontamab brengitecan extends overall survival among patients with metastatic TNBC, but it’s unclear how the investigational therapy might fit into an evolving treatment landscape.

Proton Therapy Fails to Beat IMRT in Prostate Cancer

For men with localized prostate cancer, proton therapy looks no better than IMRT when it comes to 3-year biochemical progression or GI toxicity.

Fuzuloparib Add-On Improves Metastatic Prostate Cancer rPFS

Researchers track progression-free survival after adding a PARP inhibitor to a standard regimen for metastatic castration-resistant prostate cancer.

Todays Updates

Isatuximab Boosts MRD Negativity in Multiple Myeloma

Researchers compare two different treatment regimens in 446 transplant-ineligible patients with newly diagnosed multiple myeloma in a global phase 3 trial.

Novel ADC Improves Survival in Metastatic TNBC

Izalontamab brengitecan extends overall survival among patients with metastatic TNBC, but it’s unclear how the investigational therapy might fit into an evolving treatment landscape.

Proton Therapy Fails to Beat IMRT in Prostate Cancer

For men with localized prostate cancer, proton therapy looks no better than IMRT when it comes to 3-year biochemical progression or GI toxicity.

Fuzuloparib Add-On Improves Metastatic Prostate Cancer rPFS

Researchers track progression-free survival after adding a PARP inhibitor to a standard regimen for metastatic castration-resistant prostate cancer.

Latest News

Anti-HLA antibody levels increased with the number of prior pregnancies and decreased with time since the last pregnancy, consistent with pregnancy-related alloimmunization.

Oral JAKi are not associated with an increased short-term risk for major adverse cardiovascular events or venous thromboembolism in adults aged 50 years or older with atopic dermatitis.

Across Europe, presumed consent has not removed families from organ donation decisions — or spared doctors from difficult bedside conversations.

A multicenter trial finds that a 4% tetrasodium EDTA lock solution reduces catheter related complications, driven largely by fewer occlusions requiring thrombolysis.

Any attempt to change the vaccine schedule without proper process and evidence will invite further legal action, say attorney for physician groups.

Low-dose ICS remain essential for every asthma patient, and GINA/CFA guidance favors phenotype-tailored step-up strategies rather than routine dose escalation to prevent exacerbations.

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Replimune Gets Third Chance At US Approval for Skin Cancer Drug

Replimune said on Friday it plans to apply a third time for approval of its experimental skin cancer drug in the coming days ⁠after reaching an agreement with the U.S....

Kids’ Food Allergy May Take an Emotional Toll on Parents

Parents of children with food allergies may experience a greater psychosocial burden when reactions are more frequent or severe and when families follow stricter allergenic food avoidance practices.

Indoor Fragrances: Are Overlooked Health Risks Growing?

Daily exposure to indoor fragrances is drawing growing concern as clinicians report rising allergies, asthma, and air quality problems linked to scented products.

Race Car Driver’s Death and Pneumonia Risks

The tragic death of a 41-year-old NASCAR champion from pneumonia and sepsis is a reminder that the conditions can strike at any age and progress quickly.

Analysis: 'Breakneck' Ebola Epidemic Outpaces World Response

Health teams are racing to find thousands of people ⁠who may have been exposed to the virus while also grappling with myriad challenges that make it difficult to contain.

US, Mexico, Canada Announce Ebola-related Travel Measures Ahead of World Cup

The United States, Mexico and Canada on Thursday announced aligned public health travel measures for people coming ⁠from African regions at the greatest risk from Ebola,...

Should North Africa Be Concerned About Ebola?

Yes, but don’t panic, say experts.

Kenyan Court Orders Suspension of US Plan for Ebola Quarantine Facility

A Kenyan court has ordered the temporary suspension of a plan for the United States to set up an Ebola quarantine facility in the country after a lawsuit argued the site...

House Dust Mite Immunotherapy May Prevent Allergies in Kids

Preventive house dust mite sublingual immunotherapy in sensitized, symptom-free preschoolers may safely induce blocking antibodies, reduce allergic responses, and limit new sensitizations.

Don’t Ignore Mild Asthma in Children

Mild childhood asthma is often missed, risking impaired lung growth, fixed airflow obstruction and future COPD; early diagnosis and control can prevent lasting harm.

Traffic Pollution Linked to Higher Rhinosinusitis Risk

Chronic rhinosinusitis driven by different traffic pollutants may eventually require different treatments.

Bariatric Surgery Linked to Remission of Asthma in Obesity

In patients with obesity and asthma, remission of asthma and improvements in pulmonary function are seen following metabolic and bariatric surgery, according to a meta-analysis.

Guselkumab Adds PsA Structural Damage Inhibition to Label

Guselkumab is the only IL-23 inhibitor that has been proven to help stop further structural damage in patients with active psoriatic arthritis.

FDA Advisors Favor XFG Strain for Next COVID Vaccine

Experts skipped the cicada variant BA.3.2 and last year’s LP.8.1 vaccine strain and recommended monovalent XFG option.

Countries Tighten Travel Rules as Ebola Risk Rises

Governments are stepping up travel-related containment measures. Here is a list of screening steps and travel restrictions announced by different countries.

Episode 6: Secondary Hypertension and Renal Denervation

Drs Marwah Abdalla, Herbert Aronow, and Syed Ahsan discuss resistant hypertension, candidacy for renal denervation, and what procedural safety and follow-up look like in real-world practice.

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