Imcivree – Talk Bio

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FDA Extends Review Period for Rhythm Pharmaceuticals’ Imcivree (Setmelanotide) in Acquired Hypothalamic Obesity

1 month ago talkbio0Tagged Agonist, amendment, goal, Hypothalamic structure, Imcivree, MC4R protein, human, PDUFA, Phase 3 trial, review extension, Rhythm Pharmaceuticals, setmelanotide, United States Food and Drug Administration

Imcivree; Rhythm Pharmaceuticals; FDA; review extension; acquired hypothalamic obesity; setmelanotide; PDUFA goal date; Phase 3 trial; major amendment; MC4R agonist

Rhythm Pharmaceuticals Secures Expanded FDA Approval for IMCIVREE to Treat Genetic Obesity in Children as Young as 2 Years Old

12 months ago talkbio0Tagged Approved, Bardet-Biedl Syndrome, Genetic obesity, Imcivree, leptin receptor, human, Obesity, PCSK1 gene, Pediatric brand name, POMC, Rhythm, setmelanotide, United States Food and Drug Administration

Rhythm Pharmaceuticals, IMCIVREE, setmelanotide, FDA approval, genetic obesity, Bardet-Biedl syndrome, POMC, PCSK1, LEPR deficiency, pediatric obesity treatment