Rhythm Pharmaceuticals Announces FDA Acceptance of sNDA for Setmelanotide in Acquired Hypothalamic Obesity
Provided By GlobeNewswire
Last update: Aug 20, 2025
– U.S. Food and Drug Administration accepts sNDA for filing with priority review; sets PDUFA goal date of December 20, 2025 --
– European Medicines Agency accepts and validates submission for Type II variation MAA for setmelanotide to treat acquired hypothalamic obesity –
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