FDA Novel Drug Therapy Approvals for 2024
The table below is sourced from the running list of CDER’s novel drugs approvals for 2024.
| Novel Drug Approvals for 2024 | FDA | ||||
| 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 |
| 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
|
| 40. | Ziihera | zanidatamab-hrii | 11/20/2024 |
To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer
|
| 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) |
| 37. | Vyloy | zolbetuximab-clzb | 10/18/2024 |
To treat gastric or gastroesophageal junction adenocarcinoma
|
| 36. | Hympavzi | marstacimab-hncq | 10/11/2024 |
To prevent or reduce bleeding episodes related to hemophilia A or BPress Release
|
| 35. | Itovebi | inavolisib | 10/10/2024 | To treat locally advanced or metastatic breast cancer |
| 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 schizophreniaPress Release |
| 32. | Aqneursa | levacetylleucine | 9/24/2024 |
To treat Niemann-Pick disease type CPress Release
|
| 31. | Miplyffa | arimoclomol | 9/20/2024 |
To treat Niemann-Pick disease type CPress Release
|
| 30. | Ebglyss | lebrikizumab-lbkz | 9/13/2024 |
To treat moderate-to-severe atopic dermatitis
|
| 29. | Lazcluze | lazertinib | 8/19/2024 | To treat non-small cell lung cancer |
| 28. | Niktimvo | axatilimab-csfr | 8/14/2024 |
To treat chronic graft-versus-host disease (cGVHD)
|
| 27. | Livdelzi | seladelpar | 8/14/2024 | To treat primary biliary cholangitis (PBC) |
| 26. | Nemluvio | nemolizumab-ilto | 8/12/2024 | To treat prurigo nodularis |
| 25. | Yorvipath | palopegteriparatide | 8/9/2024 | To treat hypoparathyroidismDrug Trials Snapshot |
| 24. | Voranigo | vorasidenib | 8/6/2024 |
To treat Grade 2 astrocytoma or oligodendroglioma
|
| 23. | Leqselvi | deuruxolitinib | 7/25/2024 | To treat severe alopecia areata |
| 22. | Kisunla | donanemab-azbt | 7/2/2024 | To treat Alzheimer’s disease |
| 21. | Ohtuvayre | ensifentrine | 6/26/2024 |
To treat chronic obstructive pulmonary disease
|
| 20. | Piasky | crovalimab-akkz | 6/20/2024 |
To treat paroxysmal nocturnal hemoglobinuria
|
| 19. | Sofdra | sofpironium | 6/18/2024 | To treat primary axillary hyperhidrosis |
| 18. | Iqirvo | elafibranor | 6/10/2024 |
To treat primary biliary cholangitis in combination with ursodeoxycholic acid
|
| 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 pneumoniaPress 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 olderPress Release
|
| 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 scarringPress Release
|
| 4. | Tevimbra | tislelizumab-jsgr | 3/13/2024 |
To treat unresectable or metastatic esophageal squamous cell carcinoma
|
| 3. | Letybo | letibotulinumtoxinA-wlbg | 2/29/2024 |
To temporarily improve the appearance of moderate-to-severe glabellar lines
|
| 2. | Exblifep | cefepime, enmetazobactam | 2/22/2024 |
To treat complicated urinary tract infections
|
| 1. | Zelsuvmi | berdazimer | 1/5/2024 | To treat molluscum contagiosum |
Thanks a lot for providing such a detailed list for all drugs approved by FDA in year 2024. It will be very helpful for me. Please continue to provide such information, it will be very beneficial for me. Thanks a lot !