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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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16 March 2023
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16 March 2023
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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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 ...
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09 November 2022
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09 November 2022
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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03 August 2022
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03 August 2022
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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19 April 2022
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19 April 2022
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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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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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 ...