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FDA Tells Ipsen It Won t Approve Palovarotene for FOP

FDA Tells Ipsen It Won t Approve Palovarotene for FOP
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United statesUnited arab emiratesHoward mayerMetabolic drugs advisory committeeDrug administration

Ipsen receives Complete Response Letter for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva

The CRL is related to the U.S. FDA's previous request for additional information on palovarotene clinical trial data Ipsen anticipates responding to the request in the first quarter of 2023 Regulatory

France generalUnited statesUnited arab emiratesUnited kingdomAnna gibbinsHoward mayerRachel reiffHead of researchDrug administrationDevelopment for ipsenIpsen pressMetabolic drugs advisory committeeGlobal head of franchise communicationsProc intl clin councilUs head of portfolio communicationsComplete response letter

Ipsen receives Complete Response Letter for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva

Ipsen receives Complete Response Letter for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva
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France generalUnited statesUnited arab emiratesUnited kingdomAnna gibbinsHoward mayerRachel reiffHead of researchDrug administrationDevelopment for ipsenIpsen pressMetabolic drugs advisory committeeGlobal head of franchise communicationsProc intl clin councilUs head of portfolio communicationsComplete response letter

Ipsen Delivers Strong Sales Growth in the First Nine Months of 2022 and Confirms Its Full-year Guidance

Regulatory News: Ipsen (IPNIPSEY, a global specialty-driven biopharmaceutical company, today presents its sales performance for the year to date and the third

France generalUnited statesUnited kingdomDavid loewMetabolic drugs advisory committeeEpizyme incMarengo therapeutics incRegulatory newsChief executive officerMarengo therapeuticsConsumer healthcareRare diseaseWith specialty careSponsored leveli american depositary receiptNorth americaLatin america

FDA Delays Advisory Meeting on Ipsen s FOP Drug

FDA Delays Advisory Meeting on Ipsen s FOP Drug
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Clementia pharmaceuticalsMetabolic drugs advisory committeeDrug administration