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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 and Medetia join forces to accelerate early research in rare disease

In keeping with Ipsen’s drive to accelerate the research and development of transformative therapies, we are pleased to announce a new research collaboration agreement with Medetia, a biotech with extensive drug discovery and medicinal chemistry experie...


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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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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 results from Phase III RESILIENT trial evaluating Onivyde® in second-line monotherapy for small cell lung cancer

PARIS, FRANCE, 03 August 2022 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival (OS) compared to topotecan. The trial is evaluating Onivyde® (irinotecan...


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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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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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