Given the new requirement, ARS expects to resubmit the NDA for neffy in the first half of 2024.
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Remibrutinib is an investigational oral Bruton tyrosine kinase inhibitor
Suspected cases mainly occur in counties within the Southern, Midwestern, and Mid-Atlantic US Census Bureau regions.
Direct oral challenge noninferior to skin testing followed by oral challenge for patients with low-risk allergy.
Findings for randomized trial of consumption in early neonatal period and allergy development at 12 months.
Neffy is an intranasal formulation of epinephrine.
The phase 3 INVIGORATE-2 trial included 131 allergic conjunctivitis patients 18 years of age and older.
The study included 1458 children aged 5 to 11 years with a clinical history of HDM-induced allergic rhinitis.
Intranasal epinephrine was found to be well tolerated with no significant nasal pain or irritation.
Significantly more children aged 1 to 3 years receiving epicutaneous immunotherapy had treatment response at 12 months.
Neosalus Cream, Lotion Available Again for Management of Various Dermatoses
Subset of alpha-gal allergic patients show gastrointestinal symptoms without skin changes or anaphylaxis.
The sBLA is supported by data from Studies A and B of phase 3 LIBERTY-CUPID trial which included patients with CSU who were inadequately controlled on standard-of-care H1 antihistamines.
Updated review reveals supplementation does not impact rate of exacerbations requiring systemic corticosteroids
18.9 percent of children and 25.7 percent of adults had seasonal allergy; 10.8 and 7.3 percent had eczema in 2021
Odactra is an allergen extract indicated as immunotherapy for the treatment of HDM-induced allergic rhinitis.