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BioWorld - Wednesday, August 17, 2022

NDA

Home » Topics » Regulatory » NDA
  • Postponed
    Jan. 4, 2022
    By Lee Landenberger

    Applied Therapeutics pushes NDA filing in galactosemia further back

    After discussions with the FDA, Applied Therapeutics Inc. said it will again delay an NDA filing for its galactosemia treatment, AT-007, until it has more time to discuss the filing with the agency.
  • South korea flag asia
    Aug. 3, 2021
    By Doris Yu

    Antengene wins approval for Karyopharm’s selinexor as first and only XPO1 inhibitor in South Korea

    Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA.
  • South korea flag asia
    Aug. 2, 2021
    By Doris Yu

    Antengene wins approval for Karyopharm’s selinexor as first and only XPO1 inhibitor in South Korea

    Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA. The drug has been approved in Korea to treat relapsed or refractory multiple myeloma (MM) and relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with dexamethasone.
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