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.
Zolgensma is an adeno-associated virus vector-based gene therapy.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
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.