Use of the affected product can potentially lead to underdosing or overdosing due to non-uniform distribution of cyclosporine.
Your search for oral corticosteroids returned 8 results
Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody.
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
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.
Zolgensma is an adeno-associated virus vector-based gene therapy.