News
Zolgensma is an adeno-associated virus vector-based gene therapy.
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.
Drugs in the Pipeline
Efzofitimod is a potential first-in-class selective modulator of neuropilin-2 that is designed to downregulate innate and adaptive immune responses in inflammatory disease states.
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.
News
Dupixent single-dose prefilled pens feature a hidden needle and single-press auto-injection.
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 approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
News
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
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.