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

Dec 20, 2024 · "Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. FDA …

6 days ago · Drug Name Active Ingredient Approval Date FDA-approved use on approval date* 1. Datroway: datopotamab deruxtecan-dlnk: 1/17/2025: To treat unresectable or metastatic, HR …

Up to date information on the latest FDA drug approvals. Includes list of most recent approvals, the conditions approved for, and the approval history.

18 hours ago · The following are some of the notable drug approvals that occurred in January 2025. Omvoh (mirikizumab-mrkz) Humanized immunoglobulin G4 monoclonal antibody that …

Jan 2, 2025 · The FDA approved 50 new therapeutics in 2024, with green lights for a novel schizophrenia drug, a first NASH medicine and much more.

Jan 16, 2025 · The FDA approved 50 novel drugs in 2024, with small molecules dominating the landscape, accounting for 62% of approvals. Notable highlights include Voranigo for gliomas …

Jan 30, 2025 · In looking at the product mix of new drug approvals, of the 50 new drug approvals by FDA’s CDER in 2024, 34 or 68%, were small molecules (31 drugs and three …

Oct 22, 2024 · Several highly anticipated drugs may be approved in 2024 and 2025. Here are upcoming medications pending FDA approval you can expect to hear more about.

The US FDA has approved a total of 3 new drug including 2 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry . The major …