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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(Corrects executive's name from Alaa Ahmed to Alaa Hamed in paragraphs 7 and 8)

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Sanofi Says Rare Lung Disease Drug Outperforms Standard Care in Trial

(Corrects executive's name from Alaa Ahmed to Alaa Hamed in paragraphs 7 and 8)

Advance Directives When Suicide Is Involved: Ethicist

Ethicist Art Caplan discusses a recent case involving attempted suicide and advance directives

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Single Bevacizumab Dose Sustains Trabeculectomy Success

A single injection of bevacizumab given during glaucoma surgery is associated with improved chances of surgical success even 3 years after the operation, a follow-up study of a clinical trial shows.

US States Reject Anti-vaccine Bills as Public Health Groups Fight MAHA

Dozens of state anti-vaccine bills backed by "Make America Healthy Again" supporters have failed after public health groups won over Republican state lawmakers, marking a...

US Health Department Withdraws Vaccine Advisory Panel Charter

The U.S. health department has withdrawn an April charter renewal for a key vaccine ⁠advisory panel that laid out new membership rules and direction, citing an...

Britain Gets Experimental Drug From Japan to Bolster Hantavirus Response

Britain has received supplies of the antiviral drug favipiravir from Japan as part of its response to a deadly hantavirus ⁠outbreak linked to the Hondius cruise liner, the...

Latest News

The luxury polar explorer docked at the Dutch port of Rotterdam, where ⁠authorities were quarantining the last 27 people to disembark and planned to cremate a German who died.

The U.S. Centers for Disease Control and Prevention said on Sunday it mobilized response efforts following an ⁠Ebola outbreak in the Democratic Republic of Congo and Uganda,...

About 20 deaths linked to serious liver dysfunction have been reported in Japan in patients treated with Amgen's ⁠rare disease drug Tavneos.

Women with systemic lupus erythematosus are less likely to have a second delivery and more likely to experience recurrent pregnancy complications, especially preterm birth.

The biosimilar approvals do not include Simponi and Simponi Aria’s indications outside of rheumatoid arthritis and ulcerative colitis.

The COVID seasonal vaccine for 2025/2026 protects patients not only from the target strain but also from other SARS-CoV-2 variants.

News All Time

Gut Microbe Blooms Linked to Lupus Kidney Disease

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Scarring Alopecias More Common in Black People, Urban Areas

Primary lymphocytic cicatricial alopecias disproportionately affect women, Black individuals, and urban dwellers, a study finds.

Britain to Bring 10 People to UK for Precautionary Isolation After Hantavirus Outbreak

Britain said on Tuesday that 10 people from remote island territories, including cruise ship passengers and ⁠medical staff who had contact with confirmed cases in the...

Tests in Italy, Spain Come Back Negative in Global Hunt for Hantavirus

Seventeen people under observation in Italy and Spain for possible hantavirus infection have tested negative, the countries' health ministries said on Wednesday as...

NICE Clears Home Antibiotics for Stable Newborns

Updated NICE guidance allows stable newborns to switch to oral antibiotics and complete their course at home, potentially cutting hospital stays by nearly 3 days.

Guideline Advises on New Drug for ILD in Rheumatic Diseases

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Transplant-Related Immunosuppression Drives SCC Outcomes

While most clinicians are aware of the link between immunosuppression and poor outcomes, this study validates that link and clarifies the type of immunosuppression associated with the greatest risk.

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.

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.

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.

New Data Peg Three Key Steps for Reassuring Worried Patients

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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.

CMS Wants Healthier Hospital Food, But Patient Needs Vary

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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...

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...

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