- 29 June 2023
Ipsen announces positive outcome of FDA Advisory Committee on investigational palovarotene for fibrodysplasia ossificans progressiva
PARIS, FRANCE, 29 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effect...
- 24 June 2019
Ipsen Announces U.S. FDA Approval for Newly DesignedPre-Filled Syringe for Somatuline® Depot (lanreotide)
– New Syringe Designed to Help Enhance Injection Experience –Cambridge, Mass., June 24, 2019 – Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR:IPSEY), announced today that the United States Food and Drug Administration (FDA) has a...
- 16 March 2023
Ipsen receives new FDA PDUFA date for investigational palovarotene for the treatment of people with FOP
PARIS, FRANCE, 16 March 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date, for the resubmitted New Drug Application (NDA) for investigational pa...
- 10 June 2024
Ipsen’s Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis
PARIS, FRANCE, 10 June 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis ...
- 13 February 2024
Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA
PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorour...