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.
Your search for oral corticosteroids returned 17 results
News
Zolgensma Labeling Updated With Additional Safety Information
Zolgensma is an adeno-associated virus vector-based gene therapy.
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
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
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.
Drugs in the Pipeline
Tezepelumab BLA Submitted for Severe Asthma
The BLA submission is supported by data from the PATHFINDER clinical program.
Drugs in the Pipeline
Dupilumab Under Review for Pediatric Asthma
The submission was based on data from the double-blind, placebo-controlled VOYAGE trial.
Drugs in the Pipeline
Tezepelumab Cuts Exacerbations in Severe Asthma Trial
Tezepelumab is an investigational first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin.
Drugs in the Pipeline
Benralizumab Reduces OCS Use in Severe Asthma Trial
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…
News
Dupilumab Reduces Severe Asthma Attacks in Pediatric Trial
The randomized, double-blind, placebo-controlled VOYAGE trial included 408 children aged 6 to 11 years with uncontrolled persistent asthma.
