Up to date information on the latest FDA drug approvals. Includes list of most recent approvals, the conditions approved for, and the approval history. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. The US FDA approved 46 new drugs in 2025, despite a tumultuous year at the regulatory agency. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products. Orange Book The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness. Approval information by product type Drugs Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) Drug Approval Reports. FDA Expands Accelerated Approval of Sevabertinib for HER2-Mutant Non-small Cell Lung Cancer Sep 4, 2026 4:02 pm Breast Oncology The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar. Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals Novel Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products.