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.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 VOYAGE trial.
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 updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.