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517,753 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
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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
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17 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
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
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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
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11 min read
Press Releases
Join Regeneron, IBM, Ipsen and Venture Capitalists at Demy-Colton’s BioFuture™ 2024
September 11, 2024
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3 min read
Drug Development
Gilead, Ipsen Tout Phase III Primary Biliary Cholangitis Data as PDUFA Dates Loom
Gilead Sciences’ primary biliary cholangitis candidate seladelpar and Ipsen’s PBC asset elafibranor both showed encouraging Phase III results Wednesday, as they face looming FDA decision dates.
June 5, 2024
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2 min read
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Tyler Patchen
Antibody-Drug Conjugate (ADCs)
Ipsen Inks Potential $1B First-in-Class ADC Deal With Foreseen
In its second antibody-drug conjugate licensing agreement this year, Ipsen has secured exclusive rights to Foreseen Biotechnology’s FS001, which targets a novel antigen expressed across a range of solid tumors.
July 11, 2024
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1 min read
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Kate Goodwin
Press Releases
GENFIT: Positive Opinion from EMA Committee for Ipsen’s Iqirvo® (elafibranor) in Primary Biliary Cholangitis
July 26, 2024
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5 min read
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