BioSpace News Archive

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• 

  Regulatory

  FDA Warns Applied Therapeutics of ‘Objectionable Conditions’ in Govorestat Study

  The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

  December 4, 2024

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  2 min read

   · 

  Tristan Manalac
• Press Releases

  Atea Pharmaceuticals Announces Positive Results from Phase 2 Study of Bemnifosbuvir and Ruzasvir Regimen for Treatment of Hepatitis C Virus (HCV)

  December 4, 2024

   · 

  8 min read
• Press Releases

  EyePoint Announces First Patient Dosed in Second Global Phase 3 LUCIA Clinical Trial of DURAVYU™ for the Treatment of Wet Age-Related Macular Degeneration

  December 4, 2024

   · 

  11 min read
• Press Releases

  Tiziana Life Sciences Expands Phase 2 Clinical Trial for Non-Active Secondary Progressive Multiple Sclerosis to Additional Prestigious U.S. Medical Centers

  December 4, 2024

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  3 min read
• Press Releases

  ImPact Biotech Presents Updated Interim Phase 3 Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade UTUC at SUO 2024

  December 4, 2024

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  4 min read
• Press Releases

  Allay Therapeutics Receives FDA Breakthrough Therapy Designation (BTD) for ATX101 for the Treatment of Post-surgical Pain Following Total Knee Replacement Surgery

  December 4, 2024

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  3 min read
• Press Releases

  VitriVax Awarded $3.6M Grant for Polio Vaccine Development

  December 4, 2024

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  1 min read
• Press Releases

  Stoke Therapeutics Receives FDA Breakthrough Therapy Designation for Zorevunersen for the Treatment of Dravet Syndrome

  December 4, 2024

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  8 min read
• Press Releases

  Relmada Therapeutics Reports That Data Monitoring Committee (DMC) Assessment Indicates That the Phase 3 Reliance II Trial is Futile at its Interim Analysis and is Unlikely to Meet the Primary Efficacy Endpoint with Statistical Significance

  December 4, 2024

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  4 min read
• Press Releases

  Alterity Therapeutics Completes Last Patient Visit in ATH434-201 Phase 2 Clinical Trial in Early-Stage Multiple System Atrophy

  December 4, 2024

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  6 min read