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Zevra’s arimoclomol on track as GeMDAC backs NPC drug by 11-5

Aug. 2, 2024
By Randy Osborne
As the Sept. 21 PDUFA date looms for arimoclomol from Zevra Therapeutics Inc. in Niemann-Pick type C (NPC), the U.S. FDA’s newly formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) decided in favor of the drug.
BioWorld Regulatory Endocrine/metabolic Small molecule U.S. FDA