FDA Novel Drug Approvals 2024

FDA Novel Drug Approvals

Published December 20th, 2024

Detected March 13th, 2026

Summary

The FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2024, representing new molecular entities never before marketed in the U.S. This notice provides a list of these approvals and links to detailed reports and drug information.

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What changed

The FDA has published a list of 50 novel drugs approved by its Center for Drug Evaluation and Research (CDER) in 2024. These drugs are defined as new molecular entities that have not been previously approved or marketed in the U.S. The document includes a table detailing each drug's name, active ingredient, approval date, and its FDA-approved use at the time of initial approval, with links to further information such as Drug Trials Snapshots and press releases.

This information serves as a notification of recent regulatory actions by the FDA. While this document itself does not impose new compliance obligations or deadlines, it is crucial for pharmaceutical companies and drug manufacturers to stay informed about the latest drug approvals. This awareness is important for competitive analysis, market entry strategies, and understanding the evolving landscape of therapeutic options available to patients.

Source document (simplified)

Advancing Health Through Innovation: New Drug Therapy Approvals 2024 (PDF - 10 MB)

What are "Novel" Drugs?

"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 Novel Drug Therapy Approvals for 2024:

FDA Novel Drug Therapy Approvals for 2024

In 2024, CDER approved 50 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also made other important approval decisions, such as approving previously approved drugs for new uses and broader patient populations. CDER’s novel drug approvals for 2024 are listed below. For more information, download the report.

The table below is a list of CDER’s novel drugs approvals for 2024.

| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
| --- | --- | --- | --- | --- |
| 50. | Alhemo | concizumab-mtci | 12/20/2024 | For routine prophylaxis to prevent bleeding episodes in hemophilia A and B
Drug Trials Snapshot |
| 49. | Alyftrek | vanzacaftor, tezacaftor, and deutivacaftor | 12/20/2024 | For the treatment of cystic fibrosis (CF) in patients 6 years of age and older
Drug Trials Snapshot |
| 48. | Tryngolza | olezarsen | 12/19/2024 | To treat familial chylomicronemia syndrome
Drug Trials Snapshot |
| 47. | Ensacove | ensartinib | 12/18/2024 | To treat non-small cell lung cancer
Drug Trials Snapshot |
| 46. | Crenessity | crinecerfont | 12/13/2024 | To treat classic congenital adrenal hyperplasia
Press Release
Drug Trials Snapshot |
| 45. | Unloxcyt | cosibelimab-ipdl | 12/13/2024 | To treat cutaneous squamous cell carcinoma
Drug Trials Snapshot |
| 44. | Bizengri | zenocutuzumab-zbco | 12/4/2024 | To treat non-small cell lung cancer and pancreatic adenocarcinoma
Drug Trials Snapshot |
| 43. | Iomervu | iomeprol | 11/27/2024 | For use as a radiographic contrast agent
Drug Trials Snapshot |
| 42. | Rapiblyk | landiolol | 11/22/2024 | To treat supraventricular tachycardia
Drug Trials Snapshot |
| 41. | Attruby | acoramidis | 11/22/2024 | To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis
Drug Trials Snapshot |
| 40. | Ziihera | zanidatamab-hrii | 11/20/2024 | To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer
Drug Trials Snapshot |
| 39. | Revuforj | revumenib | 11/15/2024 | To treat relapsed or refractory acute leukemia
Drug Trials Snapshot |
| 38. | Orlynvah | sulopenem etzadroxil, probenecid | 10/25/2024 | To treat uncomplicated urinary tract infections (uUTI)
Drug Trial Snapshot |
| 37. | Vyloy | zolbetuximab-clzb | 10/18/2024 | To treat gastric or gastroesophageal junction adenocarcinoma
Drug Trials Snapshots: VYLOY |
| 36. | Hympavzi | marstacimab-hncq | 10/11/2024 | To prevent or reduce bleeding episodes related to hemophilia A or B
Press Release
Drug Trials Snapshot |
| 35. | Itovebi | inavolisib | 10/10/2024 | To treat locally advanced or metastatic breast cancer
Drug Trials Snapshot |
| 34. | Flyrcado | flurpiridaz F 18 | 9/27/2024 | A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction
Drug Trials Snapshot |
| 33. | Cobenfy | xanomeline and trospium chloride | 9/26/2024 | To treat schizophrenia
Press Release
Drug Trials Snapshot |
| 32. | Aqneursa | levacetylleucine | 9/24/2024 | To treat Niemann-Pick disease type C
Press Release
Drug Trials Snapshot |
| 31. | Miplyffa | arimoclomol | 9/20/2024 | To treat Niemann-Pick disease type C
Press Release
Drug Trials Snapshot |
| 30. | Ebglyss | lebrikizumab-lbkz | 9/13/2024 | To treat moderate-to-severe atopic dermatitis
Drug Trials Snapshot |
| 29. | Lazcluze | lazertinib | 8/19/2024 | To treat non-small cell lung cancer
Drug Trials Snapshot |
| 28. | Niktimvo | axatilimab-csfr | 8/14/2024 | To treat chronic graft-versus-host disease (cGVHD)
Drug Trials Snapshot |
| 27. | Livdelzi | seladelpar | 8/14/2024 | To treat primary biliary cholangitis (PBC)
Drug Trials Snapshot |
| 26. | Nemluvio | nemolizumab-ilto | 8/12/2024 | To treat prurigo nodularis
Drug Trials Snapshot |
| 25. | Yorvipath | palopegteriparatide | 8/9/2024 | To treat hypoparathyroidism
Drug Trials Snapshot |
| 24. | Voranigo | vorasidenib | 8/6/2024 | To treat Grade 2 astrocytoma or oligodendroglioma
Drug Trials Snapshot |
| 23. | Leqselvi | deuruxolitinib | 7/25/2024 | To treat severe alopecia areata
Drug Trials Snapshot |
| 22. | Kisunla | donanemab-azbt | 7/2/2024 | To treat Alzheimer’s disease
Drug Trials Snapshot |
| 21. | Ohtuvayre | ensifentrine | 6/26/2024 | To treat chronic obstructive pulmonary disease
Drug Trials Snapshot |
| 20. | Piasky | crovalimab-akkz | 6/20/2024 | To treat paroxysmal nocturnal hemoglobinuria
Drug Trials Snapshot |
| 19. | Sofdra | sofpironium | 6/18/2024 | To treat primary axillary hyperhidrosis
Drug Trials Snapshot |
| 18. | Iqirvo | elafibranor | 6/10/2024 | To treat primary biliary cholangitis in combination with ursodeoxycholic acid
Drug Trials Snapshot |
| 17. | Rytelo | imetelstat | 6/6/2024 | To treat low- to intermediate-1 risk myelodysplastic syndromes
Drug Trials Snapshot |
| 16. | Imdelltra | tarlatamab-dlle | 5/16/2024 | To treat extensive stage small cell lung cancer
Drug Trials Snapshot |
| 15. | Xolremdi | mavorixafor | 4/26/2024 | To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis)
Drug Trials Snapshot |
| 14. | Ojemda | tovorafenib | 4/23/2024 | To treat relapsed or refractory pediatric low-grade glioma
Drug Trials Snapshot |
| 13. | Anktiva | nogapendekin alfa inbakicept-pmln | 4/22/2024 | To treat bladder cancer
Drug Trials Snapshot |
| 12. | Lumisight | pegulicianine | 4/17/2024 | To use as an optical imaging agent for the detection of cancerous tissue
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 10. | Voydeya | danicopan | 3/29/2024 | To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria
Drug Trials Snapshot |
| 9. | Vafseo | vadadustat | 3/27/2024 | To treat anemia due to chronic kidney disease
Drug Trials Snapshot |
| 8. | Winrevair | sotatercept-csrk | 3/26/2024 | To treat pulmonary arterial hypertension
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 5. | Rezdiffra | resmetirom | 3/14/2024 | To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring
Press Release
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 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).