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Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

PARIS, FRANCE, 07 December 2023 - Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. An oral...


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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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Want better care? Show up like a boss.

Liz Kalina, Vice President of North America Corporate Affairs and Patient Services at Ipsen reflects on an Ipsen-sponsored panel at SXSW® focused on the power in speaking up for yourself and Becoming the CEO of Your Health....


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Life with Primary Biliary Cholangitis: Sabrina’s Story

Sabrina is a lover of nature, mother and grandmother, whose outlook on life is to make every moment count. Sabrina lives with primary biliary cholangitis (PBC), which means every day is different depending on the severity of her symptoms, but this doesn’...


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Advocating for Yourself: L. Marie’s Experience with PBC

L. Marie started her career more than 20 years ago helping others access community health programs and healthcare—a skillset she never imagined would eventually be put to use advocating for her own health after being dismissed by her doctors.  ...


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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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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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Privacy Policy

Ipsen Biopharmaceuticals, Inc., and its affiliates and subsidiaries (“Ipsen,” “we,” “our,” or “us”) respects your privacy and we recognize your need for appropriate protection and management of the information you share with us. That is why...


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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 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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