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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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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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14 November 2023
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14 November 2023
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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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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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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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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13 February 2024
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13 February 2024
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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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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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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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, ...