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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 ...
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13 June 2023
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13 June 2023
U.S. FDA approves Bylvay® for patients living with cholestatic pruritus due to Alagille syndrome
PARIS, FRANCE, 13 June 2023 – Ipsen (Euronext: IPN: ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has approved Bylvay® (odevixibat) for the treatment of cholestatic pruritus in patients from 12 mon...
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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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03 November 2021
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03 November 2021
Ipsen appoints Stewart Campbell Executive Vice President and President of North America
CAMBRIDGE, Massachusetts, November 3, 2021 — Ipsen (Euronext: IPN; ADR: IPSEY) announced today the appointment of Stewart Campbell as Executive Vice President and President of North America, effective immediately. Based in Cambridge, he will lead th...
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16 August 2023
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16 August 2023
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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11 March 2020
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11 March 2020
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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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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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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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...