Drugs in the Pipeline
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…
Drugs in the Pipeline, News
The FDA's Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
News
Zolgensma is an adeno-associated virus vector-based gene therapy.
News
The FDA has approved a prefilled pen formulation of Dupixent (dupilumab; Sanofi and Regeneron), providing another option for administering the treatment.
Drugs in the Pipeline
The submission was based on data from the double-blind, placebo-controlled VOYAGE trial.
Drugs in the Pipeline
The BLA submission is supported by data from the PATHFINDER clinical program.
Drugs in the Pipeline
Tezepelumab is an investigational first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin.
News
The BLA submission included data from the pivotal phase 3 NAVIGATOR trial that assessed tezepelumab in 1061 patients with severe, uncontrolled asthma.
News
The randomized, double-blind, placebo-controlled VOYAGE trial included 408 children aged 6 to 11 years with uncontrolled persistent asthma.
News
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
