Abstract Digital therapeutics (DTx) represent a rapidly emerging category of medical interventions that utilize evidence-based software programs to prevent, manage, or treat diseases. These technologies operate at the intersection of software engineering, clinical medicine, and behavioral pharmacology, offering novel approaches to therapeutic intervention that extend beyond conventional pharmacological treatments. Advances [...]

Abstract Rapid advances in biotechnology, genomics, and precision medicine have transformed the pharmaceutical innovation landscape, creating unprecedented opportunities for developing novel therapies such as gene therapies, cell-based treatments, RNA therapeutics, and personalized medicines. However, these scientific breakthroughs challenge traditional drug regulatory frameworks that were designed for conventional small-molecule pharmaceuticals. In [...]

Abstract The COVID-19 pandemic exposed profound structural vulnerabilities in global pharmaceutical supply chains, highlighting the strategic importance of supply chain sovereignty in ensuring access to essential medicines and medical products. Modern pharmaceutical supply networks are highly globalized, relying on complex multi-tiered systems of raw material procurement, active pharmaceutical ingredient (API) [...]