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
Zolgensma Labeling Updated With Additional Safety Information
Zolgensma is an adeno-associated virus vector-based gene therapy.
Drugs in the Pipeline
Tezepelumab BLA Submitted for Severe Asthma
The BLA submission is supported by data from the PATHFINDER clinical program.
News
Tezepelumab Gets Priority Review for Severe Asthma
The BLA submission included data from the pivotal phase 3 NAVIGATOR trial that assessed tezepelumab in 1061 patients with severe, uncontrolled asthma.
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…
News
Dupixent Asthma Indication Expanded to Include Younger Patients
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
News
Tezspire Now Available for Treatment of Severe Asthma
Tezspire is a first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine involved in the initiation and persistence of airway inflammation.
