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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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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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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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06 June 2023
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06 June 2023
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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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 November 2022
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03 November 2022
Ipsen to Highlight Expanded Oncology Portfolio and Advances in Follicular Lymphoma Research at ASH 2022
November 3, 2022 – Ipsen (Euronext: IPN; ADR: IPSEY) will highlight its expanded portfolio in hematology at the American Society of Hematology (ASH) Annual Meeting from December 10-13 following its recent acquisition of Epizyme. The company will sha...
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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...