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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Latest News

Infection Prevention in Europe, Part 2: Six Futures to 2040

Europe’s next two decades will test whether closer cooperation, trusted data sharing, and community-centered prevention can outpace fragmentation and rising infectious risks.

Apr 03 2026 This Week in Cardiology

John Mandrola offers an ACC recap of 5 big trials—Hi-PEITHO, PROTAVI, ORBITA-CTO, CHIPS-BCIS3 and CHAMPION AF

Whole Blood Transfusion Not Superior to Usual Care in Trauma

Prehospital transfusion of whole blood does not lower the risk for early death or massive transfusion than standard component therapy in patients with life-threatening hemorrhage, a trial shows.

Ped Rheumatology Referrals Often Lack Essential Information

Potentially inappropriate or poorly documented referrals require increasing amounts of time from an already overburdened specialty.

Lipid Ratio Score May Predict Asthma Exacerbation Risk

A metabolomics-based score using sphingolipid and steroid levels predicts the risk for asthma exacerbations and may help identify patients who require closer monitoring.

Novel Agent for Alopecia Areata Appears Safe, Effective

A proof-of-concept study supports the safety and efficacy of rezpegaldesleukin vs placebo for treating severe-to-very-severe alopecia areata.

Todays Updates

Gotistobart Response Rate Bests Chemo in Pretreated NSCLC

Previously treated patients with NSCLC respond to anti-CTLA-4 therapy.

Todays Updates

Gotistobart Response Rate Bests Chemo in Pretreated NSCLC

Previously treated patients with NSCLC respond to anti-CTLA-4 therapy.

Latest News

Europe’s next two decades will test whether closer cooperation, trusted data sharing, and community-centered prevention can outpace fragmentation and rising infectious risks.

John Mandrola offers an ACC recap of 5 big trials—Hi-PEITHO, PROTAVI, ORBITA-CTO, CHIPS-BCIS3 and CHAMPION AF

Prehospital transfusion of whole blood does not lower the risk for early death or massive transfusion than standard component therapy in patients with life-threatening hemorrhage, a trial shows.

Potentially inappropriate or poorly documented referrals require increasing amounts of time from an already overburdened specialty.

A metabolomics-based score using sphingolipid and steroid levels predicts the risk for asthma exacerbations and may help identify patients who require closer monitoring.

A proof-of-concept study supports the safety and efficacy of rezpegaldesleukin vs placebo for treating severe-to-very-severe alopecia areata.

News All Time

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.

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.

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.

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.

Fibromyalgia Reframed and Linked to Altered Pain Processing

The condition is best understood as a symptom-based disorder of altered pain processing with partial overlap with post-viral syndrome, but important distinctions remain.

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.

FDA Issues Alert on Liver Injuries Linked to Vasculitis Drug

US regulators urge patients to discuss with clinicians the risks of avacopan and to consider an alternative treatment to this medicine, which is approved for a rare autoimmune disease.

Nasal Epinephrine Boosts Quality of Life

The ability to avoid routine needle-carrying spiked the value of nasal spray.

When Probiotics Help and When They Harm

Network and umbrella analyses suggest certain probiotic strains or combinations reduce necrotizing enterocolitis risk in extremely premature infants and may lower mortality.

Patients Needing Interpreters Experience Delays in ED Care

Patients needing interpreters wait longer for evaluation in the emergency department; a study highlights delays in care initiation and potential inequities in treatment.

Raising Concerns in the NHS Can Come at a Cost

Doctors are told to raise safety concerns, but some face isolation, disciplinary action, and lasting career consequences when they do.

Lilly's Eczema Drug Shows Durable Long-term Response in Late-stage Study

Eli Lilly said on Friday that its eczema drug showed durable ⁠results in a late-stage post-marketing study, such as  relief from persistent  itch for up ⁠to four years in...

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