Guided, Then Penalized: A Deep Dive into the FDA’s MDMA Ruling and What it Means for Psychedelic Clinical Trials
In August 2024, the FDA rejected the New Drug Application for MDMA-assisted therapy for PTSD, sponsored by Lykos Therapeutics,...
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Oncocyte’s Promising Clinical Trial Update
Oncocyte Corporation (Nasdaq: OCX) is preparing to launch a pivotal clinical trial for its organ transplant rejection monitoring test...
Understanding the FDA’s Draft Guidance on Protocol Deviations in Clinical Investigations
The U.S. Food and Drug Administration (FDA) has released a draft guidance document titled Protocol Deviations for Clinical Investigations of...
Celz-201-DDT FDA Clearance for Chronic Lower Back Pain Trial
Creative Medical Technology Holdings (CELZ) announced positive interim data from its Phase 1/2 trial of StemSpine using AlloStem (CELZ-201-DDT),...
Kane Biotech Launches Innovative DispersinB® Acne Trial
Kane Biotech Inc. received approval from the University of Miami Health System’s Internal Review Board to begin a clinical...
Transforming Clinical Trials with AI: Insights from the Frontline
In the rapidly evolving landscape of clinical trials, technology is a game-changer. Dr. Michelle Papka, Ph.D., Founder and President...
How AstraZeneca and Mass General Brigham are Enhancing Clinical Trial Protocol Design
The SCOPE 2025 Summit showcased a groundbreaking partnership between Mass General Brigham (MGB), AstraZeneca, and Evinova, highlighting how these...
The Emergence of Superintelligence in Healthcare, Biotech, and Clinical Trials
The journey toward superintelligence unlocks extraordinary capabilities poised to revolutionize medicine and healthcare. These systems can process vast amounts...
Strategic Navigation for Clinical Trials in Mid-Size Biopharma: Insights from Almirall
At SCOPE Summit Europe, Estrella GarcÃa, PhD, an Executive Director at Almirall, shared her insights on navigating the complexities...
Navigating the Future of Endometriosis Diagnostics
In this interview, we spoke with Farideh Bischoff, PhD, Chief Medical Officer – Head of Diagnostics at HeranovaTM, about their innovative...