Novel Drug Approvals for 2025
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 2025
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 38. | Hyrnuo | sevabertinib | 11/19/2025 | To treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy |
| 37. | Redemplo | plozasiran | 11/18/2025 | To reduce triglycerides in adults with familial chylomicronemia syndrome |
| 36. | Komzifti | ziftomenib | 11/13/2025 | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options |
| 35. | Kygevvi | doxecitine and doxribtimine | 11/3/2025 | To treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger |
| 34. | Lynkuet | elinzanetant | 10/24/2025 | To treat moderate-to-severe vasomotor symptoms due to menopause |
| 33. | Jascayd | nerandomilast | 10/7/2025 | To treat idiopathic pulmonary fibrosis |
| 32. | Rhapsido | remibrutinib | 9/30/2025 | To treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment |
| 31. | Palsonify | paltusotine | 9/25/2025 | To treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an option |
| 30. | Inluriyo | imlunestrant | 9/25/2025 | To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy |
| 29. | Forzinity | elamipretide | 9/19/2025 | To improve muscle strength in patients with Barth syndrome weighing at least 30 kg |
| 28. | Keytruda Qlex | pembrolizumab and berahyaluronidase alfa-pmph | 9/19/2025 | To treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab |
| 27. | Wayrilz | rilzabrutinib | 8/29/2025 | To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids |
| 26. | Dawnzera | donidalorsen | 8/21/2025 | To prevent attacks of hereditary angioedema |
| 25. | Brinsupri | brensocatib | 8/12/2025 | To treat non-cystic fibrosis bronchiectasis |
| 24. | Hernexeos | zongertinib | 8/8/2025 | To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy |
| 23. | Modeyso | dordaviprone | 8/6/2025 | To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy Drug Trials Snapshot |
| 22. | Vizz | aceclidine | 7/31/2025 | To treat presbyopia |
| 21. | Sephience | sepiapterin | 7/28/2025 | To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet Drug Trials Snapshot |
| 20. | Anzupgo | delgocitinib | 7/23/2025 | To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response Drug Trials Snapshot |
| 19. | Ekterly | sebetralstat | 7/3/2025 | To treat acute attacks of hereditary angioedema Drug Trials Snapshot |
| 18. | Zegfrovy | sunvozertinib | 7/2/2025 | To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy |
| 17. | Lynozyfic | linvoseltamab-gcpt | 7/2/2025 | To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibody |
| 16. | Andembry | garadacimab-gxii | 6/16/2025 | To prevent attacks of hereditary angioedema Drug Trials Snapshot |
| 15. | Ibtrozi | taletrectinib | 6/11/2025 | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer Drug Trials Snapshot |
| 14. | Enflonsia | clesrovimab-cfor | 6/9/2025 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season Drug Trials Snapshot |
| 13. | Tryptyr | acoltremon | 5/28/2025 | To treat the signs and symptoms of dry eye disease Drug Trials Snapshot |
| 12. | Emrelis | telisotuzumab vedotin-tllv | 5/14/2025 | To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy Drug Trials Snapshot |
| 11. | Avmapki Fakzynja Co-Pack | avutometinib and defactinib | 5/8/2025 | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy Drug Trials Snapshot |
| 10. | Imaavy | nipocalimab-aahu | 4/29/2025 | To treat generalized myasthenia gravis Drug Trials Snapshot |
| 9. | penpulimab-kcqx | penpulimab-kcqx | 4/23/2025 | In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy Drug Trials Snapshot |
| 8. | Vanrafia | atrasentan | 4/02/2025 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression Drug Trials Snapshot |
| 7. | Qfitlia | fitusiran | 3/28/2025 | To prevent or reduce the frequency of bleeding episodes in hemophilia A or B Press Release Drug Trials Snapshot |
| 6. | Blujepa | gepotidacin | 3/25/2025 | To treat uncomplicated urinary tract infections Drug Trials Snapshot |
| 5. | Romvimza | vimseltinib | 2/14/2025 | To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity Drug Trials Snapshot |
| 4. | Gomekli | mirdametinib | 2/11/2025 | To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection Drug Trials Snapshot |
| 3. | Journavx | suzetrigine | 1/30/2025 | To treat moderate to severe acute pain Press Release Drug Trials Snapshot |
| 2. | Grafapex | treosulfan | 1/21/2025 | For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome Drug Trials Snapshot |
| 1. | Datroway | datopotamab deruxtecan-dlnk | 1/17/2025 | To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease 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, please see the most recently approved Prescribing Information (or Label) available at Drugs@FDA. You can search by drug name, active ingredient, or application number.