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 15 results
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 two phase 3 induction studies and one phase 3 maintenance study.
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 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.
The Food and Drug Administration (FDA) has approved Saphnelo (anifrolumab-fnia) for the treatment of adults with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Type I interferons (IFNs) play a role in the pathogenesis of systemic lupus erythematosus (SLE). Anifrolumab-fnia, a human immunoglobulin G1 kappa monoclonal antibody, binds to subunit 1 of…
Findings from a phase 3b trial showed that a majority of patients with severe eosinophilic asthma treated with benralizumab (Fasenra; AstraZeneca), an interleukin-5 antagonist, were able to eliminate or reduce oral corticosteroid (OCS) use. The open-label, single-arm PONENTE trial assessed the efficacy and safety of reducing OCS use after initiating treatment with benralizumab in nearly…