-
07 December 2023
-
07 December 2023
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...
-
05 June 2024
-
05 June 2024
Ipsen presents long-term elafibranor efficacy and itch-related quality of life data in patients with primary biliary cholangitis
PARIS, FRANCE, 5 June 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced new late-breaking data at the European Association for the Study of the Liver (EASL) Congress demonstrating the enduring efficacy of elafibranor in managing disease progression a...
-
20 January 2023
-
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, ...
-
23 December 2022
-
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 ...
-
16 March 2023
-
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...
-
19 April 2022
-
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...
-
03 November 2022
-
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...
-
10 June 2024
-
10 June 2024
Ipsen’s Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis
PARIS, FRANCE, 10 June 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo® (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis ...
-
13 February 2024
-
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...
-
15 November 2024
-
15 November 2024
Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus
PARIS, FRANCE, 15 November 2024 Ipsen (Euronext: IPN; ADR: IPSEY) announced today late-breaking data for Iqirvo® (elafibranor 80 mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE® study at the American Asso...