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BioWorld - Thursday, June 19, 2025

FDA

Home » Topics » Regulatory » FDA
  • 3d bispecific antibodies
    June 19, 2025

    Diagonal Therapeutics’ DIAG-723 designated orphan drug for hereditary hemorrhagic telangiectasia

    Diagonal Therapeutics Inc.’s DIAG-723 has been awarded orphan drug designation by the FDA for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the EMA has provided a positive opinion for orphan drug designation, confirming that DIAG-723 meets the criteria for designation as an orphan drug in the E.U.
  • Neuromark system 18jun25
    June 18, 2025
    By Shani Alexander

    Rising demand spurs Neurent to open new Neuromark facility

    Amid rising demand for its Neuromark system, Neurent Medical Ltd. opened a new manufacturing facility in Ireland, which will serve as the central hub for the production of the device which treats chronic rhinitis.
  • June 18, 2025
    By Marian (YoonJee) Chu

    Jyong’s $20M US IPO to help refile NDA of urological botanic drug

    Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price.
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  • Dec. 5, 2013
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    Trust in government: 23 more reasons for suspicions

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    By Jim Stommen

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