This review provides an updated overview of FDA-approved nanomedicines and those in clinical trials. Nanomedicines are defined as therapeutic or imaging agents that use nanoparticles to control biodistribution, enhance efficacy, or reduce toxicity. Fifty-one FDA-approved nanomedicines and 77 in clinical trials were identified, with 40% of trials starting in 2014 or 2015. FDA-approved materials are mainly polymeric, liposomal, and nanocrystal formulations, but there is a trend towards more complex materials like micelles, protein-based nanoparticles, and inorganic particles. The review highlights different material categories and recent approvals or trials. Future perspectives include more targeted materials, multi-functional materials (theranostics), and complex materials that blur traditional categories. A key challenge is classifying new materials and determining required testing for safety and toxicity before product availability. Nanomedicines, like traditional drugs, require pre-market authorization by the FDA. They undergo pre-clinical and clinical validation. The field is rapidly evolving, with a threefold increase in clinical trials involving nano-sized components in three years. The interaction of nanomedicines with biological environments depends on particle properties and surrounding media. Particle size, shape, and surface chemistry affect biodistribution, clearance, and toxicity. Small particles are cleared via the kidneys, while larger particles are cleared through the liver and MPS. The desired clearance mechanism influences nanomedicine design. Protein adsorption forms a protein corona, which can lead to nanoparticle aggregation or phagocytosis. Researchers are developing design criteria for predictable nanomedicine behavior, but size, shape, and surface chemistry affect tissue accumulation and cell uptake. Nanomedicines are drugs or biologics incorporating nanoparticles to improve targeting, reduce toxicity, or enhance efficacy. They are typically administered orally or intravenously. Most are conjugated to existing drugs to alter pharmacokinetic and pharmacodynamic properties. Passive targeting relies on non-specific accumulation in diseased tissue, while active targeting uses ligands on nanoparticle surfaces to target specific cells. Only one active targeting nanomedicine, Ontak, is FDA approved. The FDA regulates nanomedicines similarly to other drugs, with a 10–15 year approval process and $1 billion per new drug. Pre-clinical testing involves animal studies to demonstrate efficacy, safety, and toxicity. Understanding physicochemical parameters and manufacturing processes is crucial. The NCL provides guidance and testing protocols for nanomedicines. Further research is needed to predict material behavior in biological systems.This review provides an updated overview of FDA-approved nanomedicines and those in clinical trials. Nanomedicines are defined as therapeutic or imaging agents that use nanoparticles to control biodistribution, enhance efficacy, or reduce toxicity. Fifty-one FDA-approved nanomedicines and 77 in clinical trials were identified, with 40% of trials starting in 2014 or 2015. FDA-approved materials are mainly polymeric, liposomal, and nanocrystal formulations, but there is a trend towards more complex materials like micelles, protein-based nanoparticles, and inorganic particles. The review highlights different material categories and recent approvals or trials. Future perspectives include more targeted materials, multi-functional materials (theranostics), and complex materials that blur traditional categories. A key challenge is classifying new materials and determining required testing for safety and toxicity before product availability. Nanomedicines, like traditional drugs, require pre-market authorization by the FDA. They undergo pre-clinical and clinical validation. The field is rapidly evolving, with a threefold increase in clinical trials involving nano-sized components in three years. The interaction of nanomedicines with biological environments depends on particle properties and surrounding media. Particle size, shape, and surface chemistry affect biodistribution, clearance, and toxicity. Small particles are cleared via the kidneys, while larger particles are cleared through the liver and MPS. The desired clearance mechanism influences nanomedicine design. Protein adsorption forms a protein corona, which can lead to nanoparticle aggregation or phagocytosis. Researchers are developing design criteria for predictable nanomedicine behavior, but size, shape, and surface chemistry affect tissue accumulation and cell uptake. Nanomedicines are drugs or biologics incorporating nanoparticles to improve targeting, reduce toxicity, or enhance efficacy. They are typically administered orally or intravenously. Most are conjugated to existing drugs to alter pharmacokinetic and pharmacodynamic properties. Passive targeting relies on non-specific accumulation in diseased tissue, while active targeting uses ligands on nanoparticle surfaces to target specific cells. Only one active targeting nanomedicine, Ontak, is FDA approved. The FDA regulates nanomedicines similarly to other drugs, with a 10–15 year approval process and $1 billion per new drug. Pre-clinical testing involves animal studies to demonstrate efficacy, safety, and toxicity. Understanding physicochemical parameters and manufacturing processes is crucial. The NCL provides guidance and testing protocols for nanomedicines. Further research is needed to predict material behavior in biological systems.