US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia
Pharmaceutical Technology
MARCH 2, 2023
The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication. The European Medicines Agency (EMA) is also reviewing Reata’s marketing authorisation application (MAA) for SKYCLARYS in Europe. There are three more drug candidates with major trial readouts that are expected in 2023.
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