Drugs in the Pipeline, News
FDA Grants Fast Track Designation to Orismilast for Atopic Dermatitis
The FDA's Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
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News
Saphnelo Approved for Systemic Lupus Erythematosus
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…
Drugs in the Pipeline
Vamorolone Under Review for Duchenne Muscular Dystrophy
Vamorolone is a first-in-class dissociative steroidal drug that retains the anti-inflammatory activity of corticosteroids but with a novel mechanism of action.
News
Yescarta Labeling Updated to Include Prophylactic Corticosteroid Use
The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
News
Cibinqo Approved for Refractory, Moderate to Severe Atopic Dermatitis
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.
News
Rinvoq Gains FDA Approval for Atopic Dermatitis
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.
News
Zolgensma Labeling Updated With Additional Safety Information
Zolgensma is an adeno-associated virus vector-based gene therapy.
