Ipsen Biopharmaceuticals, Inc.

583 articles about Ipsen Biopharmaceuticals, Inc.

• Exelixis and Ipsen Announce Positive Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer

  8/21/2023

  Exelixis, Inc. and Ipsen announced that the global phase 3 CONTACT-02 pivotal trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival at the primary analysis.

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  Week in Review: Obesity Drug Race, Ipsen Therapy Finally Gets Approval and More

  8/18/2023

  Boehringer Ingelheim will launch three Phase III studies for its obesity drug candidate; third time is a charm for Ipsen as it gets FDA approval; and Pfizer takes multiple myeloma battle to J&J.
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  FDA Approves Ipsen’s Palovarotene for Ultra-Rare Bone Disease

  8/17/2023

  After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.
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  FDA Action Alert: Ipsen, Revance, Neurocrine and Regeneron

  8/14/2023

  The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
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  5 Highly Anticipated FDA Decisions for Rare Diseases Coming This Year

  7/28/2023

  The first half of this year saw milestone approvals for rare disease therapies, and the FDA has several more such decisions on its calendar in the second half of 2023.

• Ipsen delivers solid H1 2023 results and upgrades its full-year guidance

  7/27/2023

  Ipsen, a global specialty-care biopharmaceutical company, presents its financial results for the first half of 2023.

• Ipsen provides update on E.U. Marketing Authorization Application for Bylvay® for cholestatic pruritus in patients with Alagille syndrome  

  7/21/2023

  Ipsen (Euronext: IPN: ADR: IPSEY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Bylvay® (odevixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged six months or older.

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  Ipsen, Genfit Tout Phase III Data for Liver Disease Drug, Seek FDA and EMA Approvals

  6/30/2023

  The companies Friday reported positive late-stage results for elafibranor as a second-line treatment for primary biliary cholangitis, a rare liver disease.
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  Ipsen Wins FDA's Adcomm Support for Rare Disease Drug

  6/29/2023

  An FDA advisory committee voted Wednesday that Ipsen’s fibrodysplasia ossificans progressive candidate palovarotene was effective and the benefits of the drug outweighed its risks.

• Ipsen announces positive outcome of FDA Advisory Committee on investigational palovarotene for fibrodysplasia ossificans progressiva

  6/29/2023

  Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effective treatment, with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP).

• Ipsen announces U.S. FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma

  6/14/2023

  Ipsen announced that the U.S. Food and Drug Administration has accepted its supplemental new drug application Onivyde® plus 5 fluorouracil/leucovorin and oxaliplatin as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma.

• Correction: Ipsen announces U.S. FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma

  6/14/2023

  Ipsen announced that the U.S. Food and Drug Administration has accepted its supplemental new drug application Onivyde® plus 5 fluorouracil/leucovorin and oxaliplatin as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma.

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  FDA Action Alert: BMS, GSK, Ironwood, Ipsen/Albireo

  6/12/2023

  The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.

• Ipsen receives CHMP negative opinion, following re-examination of potential first FOP treatment in the E.U.

  5/26/2023

  Ipsen announced that the re-examination of palovarotene as a potential treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva, by the Committee for Medicinal Products for Human Use of the European Medicines Agency confirms the negative opinion given in January 2023.

• Ipsen to present new Bylvay® (odevixibat) data at annual ESPGHAN congress, showcasing commitment to furthering treatment for rare cholestatic liver diseases

  5/17/2023

  Ipsen announced that new data from its growing rare disease portfolio will be presented at the 55th Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, taking place in Vienna, Austria 17-20 May 2023.

• Ipsen delivers robust sales growth in the first quarter of 2023 and confirms its full-year guidance

  4/27/2023

  Ipsen, a global specialty-driven biopharmaceutical company, presents its sales performance for the first quarter of 2023.

• Ipsen appoints Sandra Silvestri as EVP, Chief Medical Officer and Head of Global Medical Affairs, Patient Safety and Patient Affairs

  4/24/2023

  Ipsen, a global specialty-driven biopharmaceutical company, announced the appointment of Sandra Silvestri, M.D., Ph.D., as EVP, Chief Medical Officer and Head of Global Medical Affairs, Patient Safety and Patient Affairs, effective 5 May 2023.

• Ipsen, Université de Montréal and IRICoR broaden existing oncology partnership, with an exclusive license agreement and two new discovery-stage programs

  2/15/2023

  Ipsen, Université de Montréal and IRICoR announce that Ipsen has exercised its option to acquire exclusive rights to a pre-clinical stage program with potential oncology applications.

• Ipsen presents strong full-year 2022 results and guidance for 2023

  2/9/2023

  Ipsen, a global specialty-driven biopharmaceutical company, presents its financial results for the year and the fourth quarter of 2022.

• Ipsen Receives CHMP Negative Opinion for Palovarotene as a Treatment for Fibrodysplasia Ossificans Progressiva in E.U.

  1/27/2023

  Ipsen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended not to grant marketing authorization for investigational palovarotene as a treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva.