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Ipsen presents long-term elafibranor efficacy and itch-related quality of life data in patients with primary biliary cholangitis    

PARIS, FRANCE, DD June 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced new late-breaking data at the European Association for the Study of the Liver (EASL) Congress demonstrating the enduring efficacy of elafibranor in managing disease progression ...


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Ipsen appoints Keira Driansky as EVP, President of North America

PARIS, FRANCE, 2 May 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, announced today the appointment of Keira Driansky as EVP, President of North America, effective May 13, 2024. She will serve on the Executiv...


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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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Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

PARIS, FRANCE, 07 December 2023 - Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. An oral...


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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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Ipsen and GENFIT Announce Positive Results from Phase III ELATIVE trial of elafibranor in patients with primary biliary cholangitis, a rare cholestatic liver disease

PARIS, FRANCE, 30 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced positive topline data from the pivotal ELATIVE Phase III trial. In the trial the efficacy and safety of elafibranor, an investigat...


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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...


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Ipsen announces U.S. FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma

PARIS, FRANCE, 14 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) Onivyde® (irinotecan liposome injection) plus ...


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