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529,895 Results for "ipsen s a s".
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FDA
GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen’s Iqirvo® for Primary Biliary Cholangitis
GENFIT announced the achievement of a historic corporate milestone: the U.S. Food and Drug Administration accelerated approval of Iqirvo1 2 80 mg tablets – as unveiled today by Ipsen – as a first-in-class treatment for PBC in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
June 10, 2024
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15 min read
FDA
Ipsen, Genfit’s Elafibranor Wins FDA Approval for Primary Biliary Cholangitis
Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.
June 11, 2024
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2 min read
·
Tristan Manalac
Ipsen’s Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis
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 (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
June 10, 2024
·
17 min read
Press Releases
Ipsen delivers strong sales in the first quarter 2025 and confirms its full-year guidance
April 16, 2025
·
7 min read
Press Releases
Ipsen announces issuance of €500 million inaugural Rated Public Bond
March 19, 2025
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8 min read
Press Releases
GENFIT: positive late-breaking Phase 2 data for elafibranor in Primary Sclerosing Cholangitis (PSC) to be presented by Ipsen at EASL Congress 2025
April 29, 2025
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8 min read
Press Releases
Ipsen’s Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease
September 24, 2024
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10 min read
Press Releases
Ipsen appoints Olivia Brown as Executive Vice-President, Global Head of Neurotoxins
March 12, 2025
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6 min read
Press Releases
GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA Accelerated Approval
September 23, 2024
·
5 min read
Press Releases
Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade
September 20, 2024
·
11 min read
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