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BioWorld - Sunday, March 22, 2026

NDA

Home » Topics » Regulatory » NDA
  • Alopecia
    March 19, 2026
    By Tamra Sami

    Kintor’s KX-826 meets phase III endpoints in alopecia

    Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.
  • Feb. 24, 2026
    By Marian (YoonJee) Chu

    Takeda’s oral narcolepsy drug steps closer to FDA approval

    The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.

  • Feb. 11, 2026
    By Marian (YoonJee) Chu

    Takeda’s oral narcolepsy drug steps closer to FDA approval

    The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.

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Blog Posts

  • Feb. 12, 2014
    By Jennifer Boggs

    Drug pricing: Are we paying for efficacy or innovation?

  • Oct. 28, 2013
    By Marie Powers

    Patient Experience Still Undervalued in Regulating Drugs

  • May 17, 2012
    By Michael Harris

    What Drug Problem?

  • Nov. 6, 2011
    By Anette Breindl

    Medical Progress Is Real

  • May 19, 2011
    By Anette Breindl

    Race To Nowhere

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