A new PDUFA date for the treatment is now June 21, 2019; the FDA did not request additional studies from the Company.
This was the first study to demonstrate the safety of peanut oral immunotherapy among preschool-aged children when administered as routine therapy in a hospital or clinic instead of a clinical trial setting.
The combination of intranasal azelastine plus fluticasone is more effective in reducing symptom scores in patients with allergic rhinitis.
The Penicillin Skin Test Kit, containing all relevant penicillin allergenic determinants, demonstrated high negative predictive value in patients with convincing histories of immediate-type penicillin allergy.
Patients with chronic rhinosinusitis were at higher risk for developing depression and anxiety.
The Food and Drug Administration has accepted for review the Biologics License Application for AR101 (Aimmune Therapeutics) to reduce the risk of anaphylaxis following accidental exposure to peanut.
Children with both atopic dermatitis and food allergy have stratum corneum abnormalities that distinguish them from other atopic dermatitis endotypes and children without atopic disease.
The FDA has accepted Priority Review Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis.