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BioWorld - Thursday, February 19, 2026

NDA

Home » Topics » Regulatory » NDA
  • 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.

  • Glass of water and tablets
    Feb. 10, 2026
    By Marian (YoonJee) Chu

    Genentech plans NDA for multiple sclerosis pill with study win

    Genentech Inc. is covering more bases in multiple sclerosis, with its latest swing on fenebrutinib hitting a rare phase III noninferiority win against Ocrevus (ocrelizumab) in primary progressive multiple sclerosis.
  • Feb. 4, 2026
    By Marian (YoonJee) Chu

    Hair loss drugmaker Veradermics floats upsized $256M US IPO

    Veradermics Inc. raised $256.3 million from an IPO on the New York Stock Exchange Feb. 4. The proceeds will fund three ongoing phase II/III clinical trials of VDPHL-01, its novel oral formulation of Rogaine (minoxidil) to treat pattern hair loss in men and women.
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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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  • Michael Harris
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