Zolgensma is an adeno-associated virus vector-based gene therapy.
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The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
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.
Dupixent single-dose prefilled pens feature a hidden needle and single-press auto-injection.
The BLA submission included data from the pivotal phase 3 NAVIGATOR trial that assessed tezepelumab in 1061 patients with severe, uncontrolled asthma.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
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…
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.
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.