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24 Août 2023
Ipsen to Acquire Clementia Pharmaceuticals to Significantly Boost Rare Disease Portfolio
Paris and Montréal, 25 February 2019 – Ipsen (Euronext: IPN; ADR: IPSEY) and Clementia Pharmaceuticals (NASDAQ: CMTA) today announced that they have entered into an agreement for Ipsen to acquire Clementia Pharmaceuticals, including its key late-stage ...
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26 Mai 2023
Ipsen receives CHMP negative opinion, following re-examination of potential first FOP treatment in the E.U.
PARIS, FRANCE, 26 May 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the re-examination of palovarotene as a potential treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva, by the Committee for Medicinal Product...
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26 Mai 2023
Ipsen reçoit un avis négatif du Comité des médicaments à usage humain (CHMP) à la suite du réexamen du palovarotène en tant que premier traitement de FOP au sein de l’Union européenne (UE)
PARIS, FRANCE, le 26 mai 2023 – Ipsen (Euronext : IPN ; ADR : IPSEY) a annoncé aujourd'hui que, malgré le réexamen du palovarotène pour le traitement potentiel de la FOP, une maladie osseuse ultra-rare, le CHMP de l'Agence eu...
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19 Juillet 2023
Ipsen announces European Commission decision on palovarotene for the treatment of FOP
PARIS, FRANCE, 19 July 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the European Commission has followed guidance provided by the Committee for Medicinal Products for Human Use (CHMP) in May this year, and has not granted marketing autho...
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27 Janvier 2023
Ipsen receives CHMP negative opinion for palovarotene as a treatment for fibrodysplasia ossificans progressiva in E.U.
PARIS, FRANCE, 27 January 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended not to grant marketing authorization for investi...
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16 Août 2023
Les autorités réglementaires américaines (FDA) approuvent le médicament d’Ipsen SOHONOS™ (capsules de palovarotène), premier et unique traitement pour les personnes atteintes de fibrodysplasie ossifiante progressive
PARIS, FRANCE, le 16 août 2023 – Ipsen (Euronext : IPN ; ADR : IPSEY) annonce aujourd'hui l'approbation par les autorités réglementaires américaines (Food and Drug Administration, FDA) de SOHONOS™ (capsules de palovarotène) en tant que rétinoïde...
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29 Juin 2023
Ipsen annonce les résultats positifs du comité consultatif de la FDA sur le palovarotène expérimental pour la fibrodysplasie ossifiante progressive
« Nous sommes heureux du vote majoritaire du Comité consultatif de la FDA en faveur du palovarotène, qui témoigne du potentiel de ce médicament dans la prise en charge des consequences graves de la FOP. La mobilité est considérablement restreinte ch...
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16 Mars 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...
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08 Février 2024
Building on solid FY 2023 results, Ipsen anticipates four launches in 2024
PARIS, FRANCE, 8 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the year and final quarter of 2023....