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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A rodent-borne virus with a scary name. A mid-ocean cruise ship in quarantine. Several people dead and more falling sick.

Debate: Fast or Slow Correction of Chronic Hyponatremia?

Guidelines advise slow serum sodium correction to avoid osmotic demyelination, but recent data suggest that risk is low, and rapid correction may produce better outcomes.

NICE Backs First Immunotherapy for Resectable Gastric Cancer

NICE has recommended durvalumab for NHS use in England as part of perioperative treatment for adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.

Idiopathic Acute Pancreatitis: Are Hidden Causes Missed?

Researchers note that microlithiasis and biliary sludge are common causes of presumed idiopathic pancreatitis, which standard ultrasound often fails to detect.

Novel IL-17A Inhibitor Shows Efficacy in Axial SpA

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Combo Therapy Tied to Better Quality of Life in Rhinitis

In patients with allergic rhinitis, fixed combinations of intranasal antihistamines and corticosteroids are tied to better quality-of-life outcomes than oral or intranasal antihistamines alone.

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Clinicians continue prescribing antibiotics unnecessarily despite growing evidence supporting shorter, targeted, and reassessed treatment strategies.

France Expands 2026 Vaccination Rules Amid Resurgence

Nearly 300 experts warn that rising vaccine misinformation is reversing gains — measles and meningococcal infections are resurging while France updates the 2026 schedule.

Can Concurrent Boost Safely Shorten Breast Cancer Radiation?

Patients were randomly assigned 1:1 to receive either concurrent radiation dose escalation to the lumpectomy cavity during whole-breast irradiation or sequential boost after whole-breast irradiation.

FDA Expands Use of T-DXd in Early HER2+ Breast Cancer

The agency OK’d trastuzumab deruxtecan for two indications in HER2-positive early-stage breast cancer, covering both the neoadjuvant and adjuvant settings.

Todays Updates

Antibiotic Stewardship: Five Tips to Reduce Resistance

Clinicians continue prescribing antibiotics unnecessarily despite growing evidence supporting shorter, targeted, and reassessed treatment strategies.

France Expands 2026 Vaccination Rules Amid Resurgence

Nearly 300 experts warn that rising vaccine misinformation is reversing gains — measles and meningococcal infections are resurging while France updates the 2026 schedule.

Can Concurrent Boost Safely Shorten Breast Cancer Radiation?

Patients were randomly assigned 1:1 to receive either concurrent radiation dose escalation to the lumpectomy cavity during whole-breast irradiation or sequential boost after whole-breast irradiation.

FDA Expands Use of T-DXd in Early HER2+ Breast Cancer

The agency OK’d trastuzumab deruxtecan for two indications in HER2-positive early-stage breast cancer, covering both the neoadjuvant and adjuvant settings.

Latest News

A rodent-borne virus with a scary name. A mid-ocean cruise ship in quarantine. Several people dead and more falling sick.

Guidelines advise slow serum sodium correction to avoid osmotic demyelination, but recent data suggest that risk is low, and rapid correction may produce better outcomes.

NICE has recommended durvalumab for NHS use in England as part of perioperative treatment for adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.

Researchers note that microlithiasis and biliary sludge are common causes of presumed idiopathic pancreatitis, which standard ultrasound often fails to detect.

Compared with placebo, vunakizumab 120 mg significantly improves signs and symptoms of radiographic axial spondyloarthritis at week 16, with sustained efficacy through week 32.

In patients with allergic rhinitis, fixed combinations of intranasal antihistamines and corticosteroids are tied to better quality-of-life outcomes than oral or intranasal antihistamines alone.

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TNF Plus IL-23 Inhibition for PsA: Better Than IL-23 Alone?

Patients with active psoriatic arthritis who have an inadequate response to TNF inhibitors, mainly those with elevated C-reactive protein levels, may benefit from guselkumab plus golimumab therapy.

Ultraprocessed Food Intake Tied to High Asthma Risk in Kids

High consumption of heavily processed foods is linked to an increased risk for asthma in young children during early school years.

Is ChatGPT Health Ready for Emergency Triage?

Large language models performed better after full clinical data became available, raising concerns about early triage decision-making.

New Data Peg Three Key Steps for Reassuring Worried Patients

Missing even one of the steps can leave patients feeling unsatisfied, frustrated, or dismissed, new research suggests.

Hantavirus-hit Ship Sets Sail for Netherlands as Final Passengers Evacuated in Tenerife

The hantavirus-hit MV Hondius departed the Spanish island of Tenerife for the Netherlands on Monday as the last six passengers and some crew members were evacuated from the...

Germany Monitors Four Hantavirus Contacts in Frankfurt

Four German contacts from the hantavirus-hit cruise ship are being monitored in a special isolation unit at Frankfurt University Hospital ⁠after arriving overnight.

US Says 18 Passengers Flown Back After Hantavirus Outbreak on Ship

U.S. Department of Health and Human Services officials said on Monday that 18 passengers from the luxury cruise ship hit by a hantavirus outbreak were flown back to the...

CMS Wants Healthier Hospital Food, But Patient Needs Vary

Federal agency wants hospitals to more closely follow new Dietary Guidelines for Americans.

Hantavirus Protocol Breach At Dutch Hospital as Medics Race to Curb Spread

A Dutch hospital has quarantined 12 staff members as a preventive measure after blood and urine from a hantavirus patient were handled without observing strict protocols, as...

Language Models as Emergency Room Decision Support

A Science study finds modern large language models often match or exceed physicians in emergency room diagnostic decisions, especially at initial triage, but real-world trials remain essential.

26-Year-Old Man With Posttransfusion Hyperhemolysis

Severe posttransfusion hyperhemolysis in a sickle cell patient produced profound anemia and lactic acidosis; terminal complement blockade with eculizumab stabilized hemolysis and enabled recovery.

Exclusive-Kennedy's Health Officials Explored US Ban Of Some Widely Used Antidepressants, Sources Say

U.S. health department officials last week explored whether they could ban certain drugs in a widely prescribed class of antidepressants as Health Secretary Robert F....

Four Factors Keep ‘At-Risk’ Group Arthritis-Free at 10 Years

People with ‘good’ prognostic factors at baseline are less likely to progress to rheumatoid arthritis at 5 and 10 years after presentation, a cohort study finds.

Reduced Kidney Function Tied to Lower Remission Rates in RA

For patients with rheumatoid arthritis and reduced kidney function, remission after drug therapy is less likely than for patients with preserved kidney function.

Early Trauma May Shape Outcomes in Childhood-Onset Lupus

Adverse childhood experiences are common in children with systemic lupus erythematosus and are linked to higher odds of neuropsychiatric lupus, a cohort study finds.

MHRA Approves New Prophylactic for Rare Swelling Disorder

The MHRA has approved donidalorsen for long-term prevention of hereditary angioedema, a rare disorder causing potentially life-threatening swelling.

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