Novel Drug Approvals for 2024
Helping Guide the Way for New Medicines
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive assessment. To do so, CDER relies on its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat.
A Wide Range of Products
Each year, CDER approves a wide range of new drugs and biological products:
- Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER and organized by calendar year. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved by the Center for Biologics Evaluation and Research.
- Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
New Molecular Entities (NMEs)
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that FDA has previously approved. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
---|---|---|---|---|
17. | Rytelo | imetelstat | 6/6/2024 | To treat low- to intermediate-1 risk myelodysplastic syndromes |
16. | Imdelltra | tarlatamab-dlle | 5/16/2024 | To treat extensive stage small cell lung cancer |
15. | Xolremdi | mavorixafor | 4/26/2024 | To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) |
14. | Ojemda | tovorafenib | 4/23/2024 | To treat relapsed or refractory pediatric low-grade glioma |
13. | Anktiva | nogapendekin alfa inbakicept-pmln | 4/22/2024 | To treat bladder cancer |
12. | Lumisight | pegulicianine | 4/17/2024 | To use as an optical imaging agent for the detection of cancerous tissue |
11. | Zevtera | ceftobiprole medocaril sodium | 4/3/2024 | To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia Press Release |
10. | Voydeya | danicopan | 3/29/2024 | To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria |
9. | Vafseo | vadadustat | 3/27/2024 | To treat anemia due to chronic kidney disease |
8. | Winrevair | sotatercept-csrk | 3/26/2024 | To treat pulmonary arterial hypertension |
7. | Duvyzat | givinostat | 3/21/2024 | To treat Duchenne muscular dystrophy in individuals aged 6 years and older Press Release Drug Trials Snapshot |
6. | Tryvio | aprocitentan | 3/19/2024 | To treat hypertension |
5. | Rezdiffra | resmetirom | 3/14/2024 | To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring Press Release |
4. | Tevimbra | tislelizumab-jsgr | 3/13/2024 | To treat unresectable or metastatic esophageal squamous cell carcinoma Drug Trials Snapshot |
3. | Letybo | letibotulinumtoxinA-wlbg | 2/29/2024 | To temporarily improve the appearance of moderate-to-severe glabellar lines Drug Trials Snapshot |
2. | Exblifep | cefepime, enmetazobactam | 2/22/2024 | To treat complicated urinary tract infections |
1. | Zelsuvmi | berdazimer | 1/5/2024 | To treat molluscum contagiosum Drug Trials Snapshot |
*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent A-approved Prescribing Information (click on the Drug Name).