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30 June 2023
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30 June 2023
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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26 September 2019
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26 September 2019
Ipsen Announces FDA Approval of Dysport®(abobotulinumtoxinA) for the Treatment of Upper LimbSpasticity in Children, Excluding Cerebral Palsy
– Dysport is the first and only FDA-approved botulinum toxin for treatment of both pediatricupper and lower limb spasticity1 –– Pivotal Phase 3 study demonstrated Dysport improved spasticity symptoms in children agedtwo to 17 experiencing upper limb ...
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29 June 2023
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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...
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24 June 2019
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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...
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14 June 2023
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14 June 2023
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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19 June 2019
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19 June 2019
Ipsen Celebrates Opening of New Cambridge Headquarters with Day of Service
– Ipsen officially opens North American headquarters at One Main Street and recently renovatedR&D and Global External Innovation and Partnering facilities at 650 East Kendall Street –– More than 115 employees join together to support nine local n...
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07 December 2023
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07 December 2023
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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05 June 2024
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05 June 2024
Ipsen presents long-term elafibranor efficacy and itch-related quality of life data in patients with primary biliary cholangitis
PARIS, FRANCE, 5 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 a...
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20 January 2023
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20 January 2023
Ipsen presents Phase III NAPOLI 3 trial of Onivyde® regimen demonstrating positive survival results in previously untreated metastatic pancreatic ductal adenocarcinoma at ASCO GI
PARIS, FRANCE, January 20, 2023, Ipsen (Euronext: IPN; ADR: IPSEY) today presented positive results from the pivotal Phase III NAPOLI 3 trial evaluating an investigational regimen of Onivyde® (irinotecan liposome injection), a long-circulating, ...
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23 December 2022
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23 December 2022
Ipsen receives Complete Response Letter for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva
PARIS, FRANCE, 23 December 2022 – The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for palovarotene, an investigational treatment for the reduction of new abnormal bone formation ...