NLS Pharmaceutics to Proceed with Phase 3 Clinical Program (AMAZE) for Mazindol ER for the Treatment of Narcolepsy Following FDA Review and IRB Approval of the Full Study Protocol

NLS Pharmaceutics, a Swiss clinical-stage biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with its Phase 3 clinical program for Mazindol ER in the treatment of narcolepsy. The full study protocol, called AMAZE, was reviewed by the FDA and also received approval from the independent Institutional Review Board (IRB). This milestone allow..

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  • · 2023. 7. 4.
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Hoth Therapeutics Announces IRB Approval for FDA Cleared First-In-Human Clinical Trial of HT-001 at Second Clinical Site

Hoth Therapeutics has received approval from the University of Texas MD Anderson Cancer Center Institutional Review Board (IRB) to proceed with its First-in-Human Phase 2a clinical trial of HT-001. This milestone marks multiple sites hosting the trial, as Washington University of St Louis previously approved it as well. The randomized, placebo-controlled, parallel Phase 2a dose-ranging study aim..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 15.
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