Vamorolone is a first-in-class dissociative steroidal drug that retains the anti-inflammatory activity of corticosteroids but with a novel mechanism of action.
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The CLEAR study compared clinical outcomes and health resource usage in patients with severe asthma who continued, switched, or stopped their biologic treatment.
Patients with flares more likely to have inpatient, emergency department visits
Oral corticosteroid dosage reduction sustained in open-label extension study of dupilumab
In a study, the calcineurin inhibitor tacrolimus proved to be noninferior to intravenous cyclophosphamide.
The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
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.
The approval was based on data from three phase 3 trials that evaluated the efficacy and safety of upadacitinib in patients 12 years of age and older with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Zolgensma is an adeno-associated virus vector-based gene therapy.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.