Novel Drug Approvals for 2024
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 |
| 49. | Alyftrek | vanzacaftor, tezacaftor, and deutivacaftor | 12/20/2024 | To treat cystic fibrosis |
| 48. | Tryngolza | olezarsen | 12/19/2024 | To treat familial chylomicronemia syndrome |
| 47. | Ensacove | ensartinib | 12/18/2024 | To treat non-small cell lung cancer |
| 46. | Crenessity | crinecerfont | 12/13/2024 | To treat classic congenital adrenal hyperplasia Press Release |
| 45. | Unloxcyt | cosibelimab-ipdl | 12/13/2024 | To treat cutaneous squamous cell carcinoma |
| 44. | Bizengri | zenocutuzumab-zbco | 12/4/2024 | To treat non-small cell lung cancer and pancreatic adenocarcinoma |
| 43. | Iomervu | iomeprol | 11/27/2024 | For use as a radiographic contrast agent |
| 42. | Rapiblyk | landiolol | 11/22/2024 | To treat supraventricular tachycardia |
| 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 |
| 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 |
| 33. | Cobenfy | xanomeline and trospium chloride | 9/26/2024 | To treat schizophrenia Press Release |
| 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).