The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
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Rilzabrutinib is an oral Bruton tyrosine kinase inhibitor currently in development for a number of immune-mediated diseases.
Tezspire is a first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine involved in the initiation and persistence of airway inflammation.
The FDA has approved Zeposia® (ozanimod) for moderately to severely active ulcerative colitis in adults.
Ascorbic acid level testing confirmed severe deficiency (<0.1mg/dL).
In a study, the calcineurin inhibitor tacrolimus proved to be noninferior to intravenous cyclophosphamide.
Vamorolone is a first-in-class dissociative steroidal drug that retains the anti-inflammatory activity of corticosteroids but with a novel mechanism of action.
The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.
Previous studies have shown that GLP-1RAs demonstrate a protective effect by attenuating bronchial hyperresponsiveness.