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Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody.

Use of the affected product can potentially lead to underdosing or overdosing due to non-uniform distribution of cyclosporine.

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 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.

The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.

Zolgensma is an adeno-associated virus vector-based gene therapy.