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.
| Drug Name | Active Ingredient | Approval Date | FDA-approved Use on Approval Date* |
|---|---|---|---|
| Datroway | datopotamab deruxtecan-dlnk | 1/17/2025 | To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer in patients who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Drug Trials Snapshot |
| 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 |
| Journavx | suzetrigine | 1/30/2025 | To treat moderate to severe acute pain. Press Release | Drug Trials Snapshot |
| Gomekli | mirdametinib | 2/11/2025 | To treat neurofibromatosis type 1 in patients with symptomatic plexiform neurofibromas not amenable to complete resection. Drug Trials Snapshot |
| Romvimza | vimseltinib | 2/14/2025 | To treat symptomatic tenosynovial giant cell tumor when surgical resection could cause worsening functional limitation or severe morbidity. Drug Trials Snapshot |
| Blujepa | gepotidacin | 3/25/2025 | To treat uncomplicated urinary tract infections. Drug Trials Snapshot |
| Qfitlia | fitusiran | 3/28/2025 | To prevent or reduce the frequency of bleeding episodes in hemophilia A or B. Press Release | Drug Trials Snapshot |
| Vanrafia | atrasentan | 4/02/2025 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression. Drug Trials Snapshot |
| penpulimab-kcqx | penpulimab-kcqx | 4/23/2025 | In combination with cisplatin or carboplatin and gemcitabine to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent during or after platinum-based chemotherapy and at least one other prior line of therapy. Drug Trials Snapshot |
| Imaavy | nipocalimab-aahu | 4/29/2025 | To treat generalized myasthenia gravis. Drug Trials Snapshot |
| 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 |
| 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 |
| Tryptyr | acoltremon | 5/28/2025 | To treat the signs and symptoms of dry eye disease. Drug Trials Snapshot |
| Enflonsia | clesrovimab-cfor | 6/9/2025 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season. Drug Trials Snapshot |
| Ibtrozi | taletrectinib | 6/11/2025 | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer. Drug Trials Snapshot |
| Andembry | garadacimab-gxii | 6/16/2025 | To prevent attacks of hereditary angioedema. Drug Trials Snapshot |
| 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 |
| Zegfrovy | sunvozertinib | 7/2/2025 | To treat locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy. Drug Trials Snapshot |
| Ekterly | sebetralstat | 7/3/2025 | To treat acute attacks of hereditary angioedema. Drug Trials Snapshot |
| 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 |
| Sephience | sepiapterin | 7/28/2025 | To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet. Drug Trials Snapshot |
| Vizz | aceclidine | 7/31/2025 | To treat presbyopia. Drug Trials Snapshot |
| Modeyso | dordaviprone | 8/6/2025 | To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Drug Trials Snapshot |
| 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 |
| Brinsupri | brensocatib | 8/12/2025 | To treat non-cystic fibrosis bronchiectasis. Drug Trials Snapshot |
| Dawnzera | donidalorsen | 8/21/2025 | To prevent attacks of hereditary angioedema. Drug Trials Snapshot |
| 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 |
| Keytruda Qlex | pembrolizumab and berahyaluronidase alfa-pmph | 9/19/2025 | To treat adult and pediatric patients aged 12 years and older with solid tumor indications approved for the intravenous formulation of pembrolizumab. |
| Forzinity | elamipretide | 9/19/2025 | To improve muscle strength in patients with Barth syndrome weighing at least 30 kg. Drug Trials Snapshot |
| Inluriyo | imlunestrant | 9/25/2025 | To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Drug Trials Snapshot |
| 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. Drug Trials Snapshot |
| Rhapsido | remibrutinib | 9/30/2025 | To treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment. Drug Trials Snapshot |
| Jascayd | nerandomilast | 10/7/2025 | To treat idiopathic pulmonary fibrosis. |
| Lynkuet | elinzanetant | 10/24/2025 | To treat moderate-to-severe vasomotor symptoms due to menopause. Drug Trials Snapshot |
| Kygevvi | doxecitine and doxribtimine | 11/3/2025 | To treat thymidine kinase 2 deficiency in patients who start to show symptoms at 12 years of age or younger. Drug Trials Snapshot |
| 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 |
| Redemplo | plozasiran | 11/18/2025 | To reduce triglycerides in adults with familial chylomicronemia syndrome. Drug Trials Snapshot |
| Hyrnuo | sevabertinib | 11/19/2025 | To treat locally advanced or metastatic non-squamous non-small cell lung cancer with activating HER2 tyrosine kinase domain mutations in patients who have received systemic therapy. Drug Trials Snapshot |
| Voyxact | sibeprenlimab-szsi | 11/25/2025 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. Drug Trials Snapshot |
| 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 |
| Nuzolvence | zoliflodacin | 12/12/2025 | To treat uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae. Drug Trials Snapshot |
| Cardamyst | etripamil | 12/12/2025 | To treat episodes of paroxysmal supraventricular tachycardia. Drug Trials Snapshot |
| Exdensur | depemokimab-ulaa | 12/16/2025 | To treat severe asthma characterized by an eosinophilic phenotype as add-on maintenance therapy. Drug Trials Snapshot |
| Myqorzo | aficamten | 12/19/2025 | To treat symptomatic obstructive hypertrophic cardiomyopathy. Drug Trials Snapshot |
| Yartemlea | narsoplimab-wuug | 12/23/2025 | To treat hematopoietic stem cell transplant-associated thrombotic microangiopathy. Drug Trials Snapshot |
| Nereus | tradipitant | 12/30/2025 | To treat vomiting associated with motion. |
Showing 1 to 46 of 46 entries
*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.