Rhythm Pharmaceuticals announces FDA acceptance for filing and priority review of supplemental new drug application for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome

Rhythm Pharmaceuticals

15 November 2021 - FDA sets PDUFA goal date of 16 March 2022.

Rhythm Pharmaceuticals today announced that the U.S. FDA has accepted for filing the company’s supplemental new drug application for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome or Alström syndrome.

Read Rhythm Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier