The medical landscape has been witnessing a groundbreaking shift with the advent of novel therapies aimed at tackling some of the most challenging conditions. One such development is the Phase 1/2 clinical trial of Cabaletta Bio's CAR T-cell therapy, rese-cel (resecabtagene autoleucel),
The rapid advancement of artificial intelligence (AI) has made significant strides in many sectors, and the realm of healthcare is no exception. Among the promising innovations is the use of AI-powered digital twins in clinical trials, particularly those targeting complex diseases like Amyotrophic
The world of personalized cancer treatment has seen groundbreaking advancements with the introduction of combination immunotherapy, particularly in the realm of metastatic gastrointestinal (GI) cancers. Researchers at the National Cancer Institute (NCI) have developed a transformative approach that
The recent resignation of Peter Marks as the head of the FDA's Center for Biologics Evaluation and Research (CBER) marks a significant moment for the cell and gene therapy industry. His departure has sparked widespread discussion about the future direction of the regulatory landscape and its
Bayesian methods are revolutionizing the landscape of pediatric clinical trial design by offering flexibility, precision, and ethical considerations that are crucial when dealing with vulnerable populations. These approaches are particularly suited to the unique challenges of pediatric trials,
Clinical trials have long been a cornerstone of medical research, essential for the development and approval of new drugs and treatments. However, they are often plagued by high costs, time constraints, and the complexities associated with patient recruitment. In recent years, the transformative
