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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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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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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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Understanding the true impact of living with FOP

This year marks the 17th anniversary since the discovery of the ACVR1 gene was announced, a major scientific milestone in fibrodysplasia ossificans progressiva (FOP) research that helped us understand what causes the condition. On April 23, ...


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Ipsen Announces Decision to Permanently Discontinue Distribution of NutropinAq® (somatropin) cartridges

Ipsen is committed to bringing innovative medicines to the rare disease community where a significant unmet need exists and innovation in treatments is lacking....


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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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Offering support to those impacted in Turkey & Syria

We are deeply saddened by the tragic earthquake across Turkey and Syria and the worsening humanitarian crisis. Our thoughts are with all of those impacted by the devastating events and our gratitude to those who are bravely leading the rescue efforts....


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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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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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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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