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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Early Warning Scores Fairly Accurate in Older Adults in ED

Early warning scores fairly predict 24-h deterioration in adults aged 80 years or older in the emergency department, with the Rapid Emergency Medicine Score more consistent and improving with age.

GLP-1 Drugs Under Scrutiny: How Real Are the Risks?

Gastrointestinal adverse effects remain a key barrier to continued use of these agents, with slower dose titration emerging as a strategy to improve tolerability and adherence.

Mediterranean Diet Linked to Lower Adult-Onset Asthma Risk

Clinicians can reasonably include Mediterranean-style eating in respiratory prevention counseling — alongside smoking cessation, exercise, weight control, and exposure reduction.

Ciprofloxacin for Transplant Prophylaxis: Time to Rethink?

In allogeneic haematopoietic cell transplant recipients, ciprofloxacin prophylaxis may reduce bloodstream infections but is tied to higher rates of antimicrobial resistance and antibiotic use.

Docs, Lawsuit Challenge Medicare WISeR Prior Auth Experiment

Doctors in multiple states report unpaid claims and care delays under the new federal program, as a lawsuit seeks answers about AI algorithms and data security.

Abrocitinib Effective for Hand Eczema in Phase 2 Study

In the phase 2 trial, efficacy was also seen in patients with non-atopic chronic hand eczema treated with the oral JAK inhibitor.

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Why Encouragement May Not Improve Motivation in Depression

A meta-analysis identifies impaired effort-based decision making across psychiatric disorders, pointing to actionable targets for improving motivation and functional outcomes.

Assisted Dying Under Scrutiny From Medscape's Readers

Comments on a Medscape feature push past ideology to ask what evidence, oversight, and safeguards should be available for patients who choose assisted death.

Chemotherapy Boosts Survival for Older Patients With TNBC

Patients aged 70 years or older stand to benefit from adjuvant chemotherapy for triple-negative breast cancer, but the majority do not receive it.

Venetoclax Combo Shows Promise in Younger Patients With AML

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Radioligand Therapy Set to Transform Oncology Care

Nearly 400 trials and Belgium’s isotope hub signal rapid clinical diversification for radioligand therapy — but policy, funding, and system readiness must follow.

Todays Updates

Why Encouragement May Not Improve Motivation in Depression

A meta-analysis identifies impaired effort-based decision making across psychiatric disorders, pointing to actionable targets for improving motivation and functional outcomes.

Assisted Dying Under Scrutiny From Medscape's Readers

Comments on a Medscape feature push past ideology to ask what evidence, oversight, and safeguards should be available for patients who choose assisted death.

Chemotherapy Boosts Survival for Older Patients With TNBC

Patients aged 70 years or older stand to benefit from adjuvant chemotherapy for triple-negative breast cancer, but the majority do not receive it.

Venetoclax Combo Shows Promise in Younger Patients With AML

Researchers conducted a systematic review and meta-analysis for studies of acute myeloid leukemia patients with a median age less than 70 treated with HMA plus venetoclax.

Radioligand Therapy Set to Transform Oncology Care

Nearly 400 trials and Belgium’s isotope hub signal rapid clinical diversification for radioligand therapy — but policy, funding, and system readiness must follow.

Latest News

Early warning scores fairly predict 24-h deterioration in adults aged 80 years or older in the emergency department, with the Rapid Emergency Medicine Score more consistent and improving with age.

Gastrointestinal adverse effects remain a key barrier to continued use of these agents, with slower dose titration emerging as a strategy to improve tolerability and adherence.

Clinicians can reasonably include Mediterranean-style eating in respiratory prevention counseling — alongside smoking cessation, exercise, weight control, and exposure reduction.

In allogeneic haematopoietic cell transplant recipients, ciprofloxacin prophylaxis may reduce bloodstream infections but is tied to higher rates of antimicrobial resistance and antibiotic use.

Doctors in multiple states report unpaid claims and care delays under the new federal program, as a lawsuit seeks answers about AI algorithms and data security.

In the phase 2 trial, efficacy was also seen in patients with non-atopic chronic hand eczema treated with the oral JAK inhibitor.

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Bleach, Detergents Drive Pediatric Injuries From Cleaners

Children aged 1 and 2 years are at a highest risk for cleaning product-related injury.

Dupilumab Use Tied to Autoimmune Skin Disease Risk in Kids

Exposure to dupilumab is associated with an increased risk of being diagnosed with cutaneous autoimmune diseases in children with atopic dermatitis or persistent asthma.

Early-Life Exposures and JIA Risk: Antibiotics vs Infections

It remains to be determined whether the association between antibiotics exposure and risk for JIA is with infection itself or with immune dysregulation increasing susceptibility to infection.

FDA Removes Age Restriction for Neffy Nasal Spray

The FDA updates neffy nasal spray labeling, removing the age restriction for emergency allergy treatment in patients who meet a weight requirement.

Why the Vagus Nerve Is Everywhere in Medicine Right Now

A new review article summarizes the wide-ranging, evolving potential of devices that modulate vagus nerve activity.

Many Plant Foods Without Allergen Labels Pose Severe Risk

Many seeds and legumes that are not required to carry mandatory allergen warnings often cause severe allergic reactions, including anaphylaxis.

Bimekizumab Shows Rapid and Durable Psoriasis Response

Bimekizumab may deliver rapid and sustained psoriasis clearance, although its cost continues to influence treatment choices in clinical practice.

Can Immunotherapy Raise Pruritus Risk in Melanoma?

Immune-related pruritus may be observed in a quarter of patients with metastatic melanoma treated with immune checkpoint inhibitors.

Abnormal Lab Values: When Testing May Be Unnecessary

Lipase, ferritin, and tumor markers require contextual interpretation, as isolated elevations commonly reflect nonpathologic or secondary causes.

Dogs May Trigger Asthma Attacks in Kids

Continuous exposure to dogs in children with asthma is associated with a risk for asthma exacerbations but does not increase the risk for moderate-to-severe asthma.

EU Panel Expands Options in Relapsed Childhood Leukemia

The proposed EU expansion would extend access to Besponsa, a CD22-directed therapy in children with relapse of acute lymphoblastic leukemia or in whom prior treatment has failed.

SCS Closures in Ontario Spark Harm Reduction Concerns

Ontario will replace nine supervised consumption sites with HART hubs, but critics warn the lack of harm reduction could increase overdoses and strain emergency services.

Two EMA Moves Broaden Options in Hemophilia, Iron Deficiency

The European Medicines Agency has backed Feraccru for adolescent iron deficiency and expanded Hympavzi prophylaxis to hemophilia patients with or without inhibitors.

Zoster Vaccine Uptake Low in Rheumatic Disease in the US

Recombinant zoster vaccine uptake in adults with rheumatic disease reached around 10% in the 20 months following the updated 2021 recommendations, with lack of tracking and education seen as barriers.

Emerging Norovirus Vaccines Face Scientific, Policy Hurdles

Researchers are advancing several norovirus vaccine candidates, such as oral tablet-based platforms, mRNA vaccines, and virus-like particle technologies.

Long-Term Methotrexate in JIA Shows Stable Lung Function

Long-term methotrexate treatment in children with juvenile idiopathic arthritis maintains stable lung function without clinically notable pulmonary toxicity, as per a 30-year longitudinal analysis.

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