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DYNE-251

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FDA Grants Orphan Drug Designation to DYNE-251 for DMD
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FDA Grants Orphan Drug Designation to DYNE-251 for DMD

  • Post author:Jessica Lynn
  • Post published:April 4, 2023
  • Post category:Duchenne Muscular Dystrophy

  Drug development within the rare disease space can be tricky. In many cases, there is a general lack of research and understanding around these conditions; as a result, many…

Continue Reading FDA Grants Orphan Drug Designation to DYNE-251 for DMD
DYNE-251 Earns Fast Track Designation for DMD
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DYNE-251 Earns Fast Track Designation for DMD

  • Post author:Jessica Lynn
  • Post published:November 17, 2022
  • Post category:Duchenne Muscular Dystrophy

According to an October 31, 2022 press release from muscle disease company Dyne Therapeutics, Inc. ("Dyne"), the company's therapeutic candidate DYNE-251 earned Fast Track designation from the FDA for Duchenne…

Continue Reading DYNE-251 Earns Fast Track Designation for DMD
Clinical Hold Put on IND for DYNE-251 for DMD

Clinical Hold Put on IND for DYNE-251 for DMD

  • Post author:Kendall Mason
  • Post published:January 28, 2022
  • Post category:Duchenne Muscular Dystrophy

According to a recent press release from Dyne Therapeutics, the FDA has placed a clinical hold on their Investigational New Drug (IND) application for DYNE-251. Until this hold is lifted,…

Continue Reading Clinical Hold Put on IND for DYNE-251 for DMD
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