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

Worries in Canary Islands as Hantavirus Cruise Ship Due In

The arrival this weekend of a cruise ship hit by a hantavirus outbreak is reviving memories for Canary Island residents of the COVID ⁠quarantines they experienced.

Better Outcomes Seen in Colon Cancer Patients Taking RASIs

Researchers compared outcomes of patients with colon cancer and hypertension taking RASIs in the first month after surgery with those taking other antihypertensive medications without RASIs.

Rapid Sepsis Testing Can Save Lives and Curb Costs

New report outlines significant benefits of rapid diagnosis and susceptibility testing in high-risk patients.

End-Stage Renal Disease Payment Model Falls Short of Goals

A mandatory CMS pay-for-performance model aimed at boosting home dialysis and kidney transplant rates showed no meaningful gains and imposed high financial penalties on providers.

Overlapping Inflammatory Vulvar Conditions Underrecognized

Lichen sclerosus/lichen planus overlap syndrome may signal higher neoplastic risk and warrant more aggressive treatment, a small cohort study suggests.

Questions Persist Over Echinacea for Preventing Colds

Evidence on echinacea for the prevention or treatment of respiratory infections remains inconsistent, with product variability limiting clear clinical guidance.

Todays Updates

T-DXd Reduces Residual Disease in Early Breast Cancer

Neoadjuvant trastuzumab deruxtecan combination therapy reduces the residual cancer burden in high-risk early breast cancer, even if a pathologic complete response is not achieved, shows analysis.

Todays Updates

T-DXd Reduces Residual Disease in Early Breast Cancer

Neoadjuvant trastuzumab deruxtecan combination therapy reduces the residual cancer burden in high-risk early breast cancer, even if a pathologic complete response is not achieved, shows analysis.

Latest News

The arrival this weekend of a cruise ship hit by a hantavirus outbreak is reviving memories for Canary Island residents of the COVID ⁠quarantines they experienced.

Researchers compared outcomes of patients with colon cancer and hypertension taking RASIs in the first month after surgery with those taking other antihypertensive medications without RASIs.

New report outlines significant benefits of rapid diagnosis and susceptibility testing in high-risk patients.

A mandatory CMS pay-for-performance model aimed at boosting home dialysis and kidney transplant rates showed no meaningful gains and imposed high financial penalties on providers.

Lichen sclerosus/lichen planus overlap syndrome may signal higher neoplastic risk and warrant more aggressive treatment, a small cohort study suggests.

Evidence on echinacea for the prevention or treatment of respiratory infections remains inconsistent, with product variability limiting clear clinical guidance.

News All Time

Study Highlights Gaps, Variability in Vitiligo Treatment

Many patients with vitiligo remain untreated, and those who are treated receive short, variable therapies, researchers report.

HS in Pregnancy Raises Risk for Some Adverse Outcomes

Hidradenitis suppurativa in pregnancy raises risks for hypertensive disorders, cesarean delivery, and preterm birth but not preeclampsia or stillbirth, a meta-analysis finds.

UK Regulator Clears Treatment for PBC-Related Itch

The MHRA has approved linerixibat to treat itch in adults with primary biliary cholangitis, after studies showed it reduced symptoms and improved itch-related sleep disruption.

Abortion Pill Makers Ask US Supreme Court to Restore Mail-order Access

(This May 2 story has been repeated with no changes to the text)

Three Cruise Ship Passengers Die in Suspected Hantavirus Outbreak

Three people have died and three are ill after a Netherlands-based cruise ship was hit by a suspected ⁠outbreak of hantavirus, a rodent-borne virus that can cause fatal...

South Carolina Confirms Second Measles Case in Saluda County

The South Carolina Department of Public Health on Monday confirmed a second measles ⁠case in Saluda County, saying it was linked to the initial case reported on April...

When to Call Neurosurgery for Traumatic Brain Injury

Call neurosurgery for head trauma with falling GCS (especially < 8), new focal deficits or pupillary changes, seizures, or CT showing epidural > 15 mm or subdural > 10 mm.

Early Steroid Pulses Tied to Lower Damage/Death Risk in SLE

In patients with systemic lupus erythematosus, the use of methylprednisolone pulses within the first year of diagnosis is linked to a reduced risk for organ damage or death in the long term.

Unregulated Peptides Pose Dangers to Patients

Clinicians should be aware of claims being made about unregulated peptides and the potential harms associated with these products.

Misinformation From AI Putting Patients’ Health at Risk

A survey of more than 600 Canadian physicians finds that virtually all have had to intervene to prevent harm after a patient followed misleading health information online.

Takeda's Next-gen Experimental Immune Drug Comparable to Approved Treatment in Study

Takeda Pharmaceutical said on Monday its experimental drug for primary immunodeficiency disease showed ⁠comparable immune protection to its approved therapy HyQvia in a...

NHS Rolls Out One-Minute Pembrolizumab Jab

NHS England is rolling out a subcutaneous form of pembrolizumab that cuts treatment time by up to 90% across 14 cancer types.

US Court Blocks Mail-order Access to Abortion Drugs, for Now

A U.S. appeals court on Friday temporarily blocked a federal rule allowing the abortion drug mifepristone to be dispensed through the mail, significantly curtailing access...

Triple Therapy for Asthma Earns FDA Approval

Evidence of reduced exacerbations and improved lung function supported the additional indication.

Does AD Affect Adults More With Early Onset Than With Later?

Patients with atopic dermatitis since childhood show a greater psychosocial burden than those with the disease since adolescence; however, no variation in allergic comorbidities is observed.

Noninvasive Tests Key to Identifying MASH in Primary Care

As the prevalence of liver disease continues to climb alongside diabetes and obesity, the role of the primary care physician is evolving from referral maker to frontline manager.

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