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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Todays Updates

Freeman’s Lobotomy to Deep Brain Stimulation: What Changed?

The history of lobotomy shows the risks for limited evidence and oversight, while modern approaches emphasize targeted treatment, informed consent, and rigorous evaluation.

Wide Variation Seen in Lung Screening False-Positive Rates

US radiologists vary substantially in their reading of low-dose CT lung cancer screens, highlighting a need for measures to help standardize interpretation.

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Researchers compare first-line chemotherapy regimens in older patients with classical Hodgkin lymphoma to assess whether AVD is associated with better outcomes in routine care.

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Researchers analyze individual patient data from five randomized phase 3 trials comparing PORT alone vs PORT plus hormone therapy in patients with recurrent prostate cancer.

How Low Does PSA Need to Go in Metastatic Prostate Cancer?

A new real-world analysis helps clarify the most informative prognostic PSA benchmark in men with metastatic castration-sensitive prostate cancer.

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Among critically ill patients aged 90 and older, the source of sepsis may influence short-term survival more than previously recognized.

A decline in the functioning of the cellular cleanup pathway drives disease across nearly every organ. Now drugs that restore it are heading toward the clinic.

Ultraprocessed foods may do more than add calories, with emulsifiers, sweeteners, and dyes linked to gut dysbiosis and a weakened intestinal barrier.

Evidence points to a neuroimmune pathway through which psychological stress may amplify skin inflammation, raising questions about future approaches to eczema care.

Glomerular hematuria without proteinuria or impaired kidney function in patients with systemic lupus erythematosus may indicate pathology other than lupus nephritis, a study finds.

Nearly one third of children born very preterm have abnormal pulmonary findings at preschool age, with greater bronchodilator responsiveness and a higher burden of respiratory risk factors.

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Dupilumab significantly improves sinus opacification and disease burden in patients with allergic fungal rhinosinusitis.

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Dupilumab Shows Long-Term Benefits in CRSwNP

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A multinational, retrospective, new-user active-comparator cohort study using 10 U.S. and non-U.S. administrative claims and EHR databases.

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Infection risk varies by biologic target, supporting tailored screening, vaccination, and monitoring rather than a one-size-fits-all prevention strategy.

New BTK Inhibitor Approved for Urticaria

MHRA approves oral BTK inhibitor remibrutinib, offering adults with chronic spontaneous urticaria a new option beyond antihistamines.

Uveitis May Flag Possibility of Axial Spondyloarthritis

Many patients with nongranulomatous acute anterior uveitis may be diagnosed with previously unrecognized axial spondyloarthritis after rheumatologic evaluation.

Uraemic Toxins Tied to Septic AKI Severity, Not Mortality

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Patients with T1D face a higher risk for any fractures, major osteoporotic fractures, and hip fractures than control individuals without diabetes; the risk increases as DKD becomes more severe.

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