Publication date: Sep 15, 2025
In 2024, the European Medicines Agency (EMA) recommended 114 new medicines for human use, including 48 with entirely novel active substances. These therapeutic agents span diverse areas such as oncology, neurology, infectious diseases, metabolic disorders, and vaccines. Notably, 16 (14 %) of these approvals received orphan drug designation for the treatment of rare diseases. Key milestones included the endorsement of the first drug proven to slow Alzheimer’s disease progression and the first vaccine to protect adults against chikungunya virus. Regulatory advancements played a critical role, with accelerated pathways facilitating the approval of innovative medicines to address unmet medical needs, including novel antibiotics targeting multidrug-resistant bacterial infections and therapies for antimicrobial resistance. EMA also made significant strides in addressing medicine shortages by implementing the European Shortages Monitoring Platform (ESMP) and enhancing communication with stakeholders for critical drugs such as glucagon-like peptide-1 (GLP-1) receptor agonists. This review examines the synthesis and clinical applications of newly approved drugs by the EMA in 2024, with a focus on their development pathways and therapeutic impact. By analyzing these innovative medicines, the review aims to provide insights into modern drug synthesis strategies and regulatory frameworks, fostering further advancements in pharmaceutical research and development.
| Concepts | Keywords |
|---|---|
| Alzheimer | 2024 |
| Antibiotics | Clinical applications |
| Neurology | Drug Approval |
| EMA | |
| Europe | |
| Humans | |
| NMEs | |
| Synthesis |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | diseases metabolic |
| disease | MESH | rare diseases |
| disease | MESH | disease progression |
| disease | IDO | role |
| disease | MESH | bacterial infections |