Drug Approvals and Databases | FDA
Sep 24, 2025 · Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals Novel Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic …
Approvals of FDA-Regulated Products
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 …
Novel Drug Approvals for 2025 | FDA
Nov 3, 2025 · To see the FDA-approved conditions of use [e.g., indication (s), population (s), dosing regimen (s)] for each of these products, please see the most recently approved …
New FDA Approvals for December 2025 - Guideline Central
6 days ago · The U.S. Food and Drug Administration (FDA) provides the Prescription Drug User Fee Act date which marks the deadline by which the FDA must complete its review of drug …
New FDA Drug Approvals for 2025 - Drugs.com
Nov 26, 2025 · Up to date information on the latest FDA drug approvals. Includes list of most recent approvals, the conditions approved for, and the approval history.
Drugs | FDA - U.S. Food and Drug Administration
Orange Book The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness.
Drugs@FDA - Food and Drug Administration
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 …
Biological Approvals by Year | FDA
Jun 2, 2025 · A collection of biological approval information organized by year and regulatory authorities.
FDA Approval History - Drugs.com
Nov 3, 2025 · This list consists of medications tracked by Drugs.com through the application and approval process at the U.S. Food and Drug Administration (FDA). Where possible, we have …
Notable Approvals | Drugs | FDA
Oct 25, 2024 · News about human drug-related approvals