FDA Novel Drug Approvals 2025

Advancing Health Through Innovation: New Drug Therapy Approvals 2025 (PDF - 4 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 2025

In 2025, CDER approved 46 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 2025 are listed below. For more information, download the report.

The table below is a list of CDER’s novel drugs approvals for 2025.

| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
| --- | --- | --- | --- | --- |
| 46. | Nereus | tradipitant | 12/30/2025 | To treat vomiting associated with motion |
| 45. | Yartemlea | narsoplimab-wuug | 12/23/2025 | To treat hematopoietic stem cell transplant-associated thrombotic microangiopathy |
| 44. | Myqorzo | aficamten | 12/19/2025 | To treat symptomatic obstructive hypertrophic cardiomyopathy
Drug Trials Snapshot |
| 43. | Exdensur | depemokimab-ulaa | 12/16/2025 | To treat severe asthma characterized by an eosinophilic phenotype as an Komziftiadd-on maintenance therapy
Drug Trials Snapshot |
| 42. | Cardamyst | etripamil | 12/12/2025 | To treat episodes of paroxysmal supraventricular tachycardia |
| 41. | Nuzolvence | zoliflodacin | 12/12/2025 | To treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae |
| 40. | Lerochol | lerodalcibep-liga | 12/12/2025 | To reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and exercise
Drug Trials Snapshot |
| 39. | Voyxact | sibeprenlimab-szsi | 11/25/2025 | To reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progression |
| 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
Drug Trials Snapshot |
| 37. | Redemplo | plozasiran | 11/18/2025 | To reduce triglycerides in adults with familial chylomicronemia syndrome
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 34. | Lynkuet | elinzanetant | 10/24/2025 | To treat moderate-to-severe vasomotor symptoms due to menopause
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 26. | Dawnzera | donidalorsen | 8/21/2025 | To prevent attacks of hereditary angioedema
Drug Trials Snapshot |
| 25. | Brinsupri | brensocatib | 8/12/2025 | To treat non-cystic fibrosis bronchiectasis
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 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
Drug Trials Snapshot |
| 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.

• ## Content current as of:

03/04/2026

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