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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...


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Ipsen Sponsors Pancreatic Cancer Action Network’s Purplestride Walk

Cambridge, Massachusetts (April 19th, 2022)—Ipsen supports Pancreatic Cancer Action Network (PanCAN) as a national sponsor of the organization’s PanCAN PurpleStride, their event to end pancreatic cancer. On April 30, 60 communities acros...


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Ipsen to Highlight Expanded Oncology Portfolio and Advances in Follicular Lymphoma Research at ASH 2022

November 3, 2022 – Ipsen (Euronext: IPN; ADR: IPSEY) will highlight its expanded portfolio in hematology at the American Society of Hematology (ASH) Annual Meeting from December 10-13 following its recent acquisition of Epizyme. The company will sha...


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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 ...


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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...


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Multi-National PRESTO Study Presented by ENETS with Simultaneous Publication in Advances in Therapy

– In PRESTO, almost all nurse participants (97.8%) reported a preference* for the Somatuline® Depot(lanreotide) redesigned pre-filled syringe compared with the syringe for long-acting release octreotide–CAMBRIDGE, Mass. March 11, 2020 — Ipsen Biopha...


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Onivyde® regimen demonstrated statistically significant improvement in overall survival in previously untreated metastatic pancreatic ductal adenocarcinoma

PARIS, FRANCE, 9 November 2022 – Ipsen (Euronext: IPN; ADR: IPSEY) announced the Phase III NAPOLI 3 trial of Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) met its primary endpoint d...


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Results from Ipsen’s ELATIVE® pivotal Phase III trial of elafibranor in PBC presented as late breaking data at AASLD congress and  published in New England Journal of Medicine

PARIS, FRANCE, 13 November, 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced full results from the pivotal Phase III ELATIVE® trial, which are being presented in a late-breaking oral session (Abstract #484,...


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US FDA approves Ipsen’s Sohonos™ (palovarotene) capsules, the first and only treatment for people with fibrodysplasia ossificans progressiva

PARIS, FRANCE, 16 August 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today approval by the U.S. Food and Drug Administration (FDA) of Sohonos™ (palovarotene) capsules as a retinoid indicated for the reduction in volume of new heterotopic ossific...


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