This post provides a consolidated and structured overview of FDA novel drug approvals in 2025, covering pharmaceutical products that received first-time approval in the United States during the calendar year.
Unlike the official listings published by the FDA, this page is designed to offer additional regulatory context, therapeutic grouping, and high-level insights that help healthcare professionals, pharmaceutical marketers, researchers, and policy analysts quickly understand what was approved, where innovation was concentrated, and why these approvals matter.
All information is compiled from publicly available FDA sources and is presented in a reference-friendly format, with updates made as official approvals are announced or clarified.
FDA NOVEL DRUG APPROVALS 2025 – EXECUTIVE SUMMARY
In 2025, the U.S. Food and Drug Administration (FDA) continued its emphasis on approving innovative therapies for serious and life-threatening conditions, with a strong concentration of approvals in oncology and rare diseases.
A notable proportion of novel drugs approved during the year received expedited regulatory designations, such as Priority Review, Breakthrough Therapy, or Accelerated Approval, reflecting ongoing efforts to shorten development timelines for treatments addressing unmet medical needs.
Overall, the FDA’s 2025 novel drug approval landscape highlights a sustained shift toward precision medicine, targeted biologic therapies, and specialty drugs, reinforcing long-term regulatory and industry trends observed over the past decade.
FDA DRUG APPROVALS 2025 – KEY FACTS (AT-A-GLANCE)
FDA Novel Drug Approvals 2025 – Key Facts
- Total novel drugs approved: 46
- Oncology-related approvals: 16 (Hyrnuose, Komzift, Inluriyo, Keytruda Qlex, Hernexeos, Modeysodo, Zegfrovy, Lynozyfic, Ibtrozita, Emreliste, Avmapki Fakzynja, penpulimab-kcqx, Romvimza, Gomeklim, Grafapex, and Datroway)
- Rare disease / orphan-designated drugs: 10-15
- Small-molecule drugs: 31
- Biologic therapies (including monoclonal antibodies): 15
- Drugs approved under expedited FDA pathways: 16 – 20
- First-in-class therapies: 4-7
Note: Figures are based on FDA classifications and publicly available approval data for calendar year 2025.
Novel Drug Approvals for 2025 Table
| Brand Name | Active/Generic Ingredient | Approval Date | Indication / Therapeutic Use | Therapeutic Area | Modality | Orphan Designation | Expedited Pathway(s) | First-in-Class |
| Nereus | tradipitant | 12/30/2025 | To treat vomiting associated with motion | Antiemetic / Gastrointestinal | Small-molecule | -- | -- | -- |
| Yartemlea | narsoplimab-wuug | 12/23/2025 | To treat hematopoietic stem cell transplant-associated thrombotic microangiopathy | Hematology | Biologic (mAb) | -- | -- | -- |
| Myqorzo | aficamten | 12/19/2025 | To treat symptomatic obstructive hypertrophic cardiomyopathy | Cardiovascular | Small-molecule | Yes | -- | -- |
| Exdensur | depemokimab-ulaa | 12/16/2025 | To treat severe asthma characterized by an eosinophilic phenotype as an add-on maintenance therapy | Respiratory | Biologic (mAb) | -- | -- | -- |
| Cardamyst | etripamil | 12/12/2025 | To treat episodes of paroxysmal supraventricular tachycardia | Cardiovascular | Small-molecule | -- | -- | -- |
| Nuzolvence | zoliflodacin | 12/12/2025 | To treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae | Infectious Disease | Small-molecule | No | Priority Review, QIDP | Yes |
| Lerochol | lerodalcibep-liga | 12/12/2025 | To reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia... | Cardiovascular | Biologic (Protein) | -- | -- | -- |
| Voyxact | sibeprenlimab-szsi | 11/25/2025 | To reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progression | Nephrology | Biologic (mAb) | Yes | Accelerated Approval | -- |
| 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... | Oncology | Small-molecule | Yes | Accelerated Approval | -- |
| Redemplo | plozasiran | 11/18/2025 | To reduce triglycerides in adults with familial chylomicronemia syndrome | Metabolic | RNAi / siRNA | Yes | -- | -- |
| Komzifti | ziftomenib | 11/13/2025 | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation... | Oncology | Small-molecule | Yes | -- | -- |
| Kygevvi | doxecitine and doxribtimine | 3/11/2025 | To treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger | Rare Disease / Mitochondrial | Small-molecule | Yes | -- | -- |
| Lynkuete | linzanetant | 10/24/2025 | To treat moderate-to-severe vasomotor symptoms due to menopause | Women's Health | Small-molecule | -- | -- | -- |
| Jascayd | nerandomilast | 7/10/2025 | To treat idiopathic pulmonary fibrosis | Respiratory | Small-molecule | Yes | -- | -- |
| Rhapsidore | remibrutinib | 09/30/2025 | To treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment | Immunology / Dermatology | Small-molecule | -- | -- | -- |
| Palsonify | paltusotine | 09/25/2025 | To treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an option | Endocrinology | Small-molecule | Yes | -- | -- |
| Inluriyo | imlunestrant | 09/25/2025 | To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer... | Oncology | Small-molecule | -- | -- | -- |
| Forzinity | elamipretide | 09/19/2025 | To improve muscle strength in patients with Barth syndrome weighing at least 30 kg | Rare Disease | Small-molecule (Peptide) | Yes | -- | -- |
| Keytruda Qlex | pembrolizumab and berahyaluronidase alfa-pmph | 09/19/2025 | To treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab | Oncology | Biologic | -- | -- | -- |
| Wayrilz | rilzabrutinib | 08/29/2025 | To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids | Hematology | Small-molecule | Yes | -- | -- |
| Dawnzera | donidalorsen | 08/21/2025 | To prevent attacks of hereditary angioedema | Immunology | RNAi / Oligonucleotide | Yes | -- | -- |
| Brinsupri | brensocatib | 12/8/2025 | To treat non-cystic fibrosis bronchiectasis | Pulmonology | Small-molecule | -- | -- | -- |
| 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... | Oncology | Small-molecule | -- | -- | -- |
| Modeyso | dordaviprone | 6/8/2025 | To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy | Oncology | Small-molecule | Yes | -- | -- |
| Vizz | aceclidine | 07/31/2025 | To treat presbyopia | Ophthalmology | Small-molecule | -- | -- | -- |
| Sephience | sepiapterin | 07/28/2025 | To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria... | Metabolic | Small-molecule | Yes | -- | -- |
| Anzupgo | delgocitinib | 07/23/2025 | To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable... | Dermatology | Small-molecule | -- | -- | -- |
| Ekterly | sebetralstat | 3/7/2025 | To treat acute attacks of hereditary angioedema | Immunology | Small-molecule | Yes | -- | -- |
| Zegfrovy | sunvozertinib | 2/7/2025 | To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations... | Oncology | Small-molecule | -- | -- | -- |
| Lynozyfic | linvoseltamab-gcpt | 2/7/2025 | To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy... | Oncology | Biologic (Bispecific) | Yes | -- | -- |
| Andembry | garadacimab-gxii | 06/16/2025 | To prevent attacks of hereditary angioedema | Immunology | Biologic (mAb) | Yes | -- | -- |
| Ibtrozi | taletrectinib | 11/6/2025 | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer | Oncology | Small-molecule | Yes | -- | -- |
| Enflonsia | clesrovimab-cfor | 9/6/2025 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants... | Infectious Disease | Biologic (mAb) | -- | -- | -- |
| Tryptyr | acoltremon | 05/28/2025 | To treat the signs and symptoms of dry eye disease | Ophthalmology | Small-molecule | -- | -- | -- |
| Emrelis | telisotuzumab vedotin-tllv | 05/14/2025 | To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression... | Oncology | ADC | -- | -- | -- |
| Avmapki Fakzynja | avutometinib and defactinib | 8/5/2025 | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy | Oncology | Small-molecule | -- | -- | -- |
| Imaavy | nipocalimab-aahu | 04/29/2025 | To treat generalized myasthenia gravis | Neurology | Biologic (mAb) | Yes | -- | -- |
| (No Brand Name) | penpulimab-kcqx | 04/23/2025 | In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma... | Oncology | Biologic (mAb) | Yes | -- | -- |
| Vanrafia | atrasentan | 2/4/2025 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | Nephrology | Small-molecule | Yes | -- | -- |
| Qfitlia | fitusiran | 03/28/2025 | To prevent or reduce the frequency of bleeding episodes in hemophilia A or B | Hematology | RNAi / siRNA | Yes | -- | -- |
| Blujepa | gepotidacin | 03/25/2025 | To treat uncomplicated urinary tract infections | Anti-infective | Small-molecule | -- | -- | Yes |
| Romvimza | vimseltinib | 02/14/2025 | To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation... | Oncology | Small-molecule | Yes | -- | -- |
| Gomekli | mirdametinib | 11/2/2025 | To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection | Oncology | Small-molecule | Yes | -- | -- |
| Journavx | suzetrigine | 01/30/2025 | To treat moderate to severe acute pain | Pain Management | Small-molecule | -- | -- | Yes |
| Grafapex | treosulfan | 01/21/2025 | For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation... | Oncology / Hematology | Small-molecule | Yes | -- | -- |
| Datroway | datopotamab deruxtecan-dlnk | 01/17/2025 | To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer... | Oncology | ADC | No | -- | No |
Therapeutic Area count of Drugs
Quarterly Breakdown of Drug Approval 2025
Read Also: New Drugs List 2021& 2022 approved by CDSCO
BREAKDOWN OF FDA NOVEL DRUG APPROVALS BY THERAPEUTIC AREA (2025)
Oncology
Oncology accounted for the largest share of FDA novel drug approvals in 2025, reflecting continued innovation in cancer treatment and a strong regulatory focus on therapies targeting advanced, resistant, or biomarker-defined malignancies.
16 Approved drugs in this category included targeted therapies, antibody-based treatments, and precision oncology products designed to improve outcomes in patient populations with limited existing treatment options.
Rare Diseases and Genetic Disorders
A significant number of novel drugs approved in 2025 were granted orphan drug designation, underscoring the FDA’s ongoing support for therapies addressing rare and ultra-rare conditions.
Many of these approvals targeted diseases with small patient populations and high unmet medical need, often involving innovative mechanisms of action or advanced biologic platforms.
Infectious Diseases
FDA approvals in infectious diseases during 2025 focused on addressing therapeutic gaps, including treatments for drug-resistant infections and conditions with limited existing options.
These approvals reflect continued regulatory attention to antimicrobial resistance and evolving infectious disease challenges.
Neurology and Psychiatry
Novel drug approvals in neurology and psychiatry included therapies targeting complex central nervous system disorders, such as neurodegenerative diseases and severe neurological conditions.
Despite higher clinical and regulatory complexity, this area continues to attract innovation due to substantial unmet medical needs and long-term disease burden.
Other Therapeutic Areas
Additional approvals in 2025 spanned therapeutic areas such as cardiology, dermatology, endocrinology, and immunology.
These approvals were typically more selective and often focused on niche indications or incremental therapeutic advancements.
Overall Observation
The therapeutic distribution of FDA novel drug approvals in 2025 demonstrates a concentration of innovation in high-complexity, high-impact disease areas, with oncology and rare diseases continuing to dominate the approval landscape.
UPDATE & SOURCE NOTE
This post is updated periodically based on official FDA announcements. Drug approvals are sourced from publicly available FDA publications and regulatory disclosures.
FAQ
What is a novel drug FDA?
A novel FDA drug is a New Molecular Entity (NME) with unique mechanisms or clinical benefits for unmet needs, often expedited via pathways like Breakthrough Therapy or Priority Review.Â
What are the changes in the FDA in 2025?
There are some proposals inthe FDA in 2025 that are under consideration like: (i) Enhanced AI/ML Integration, (ii) Diversity in Clinical Trials, (iii) Accelerated Pathways Expansion, and (iv) Supply Chain Resilience.
How many FDA novel drugs approved in 2025?
Total 46 New drugs approved by FDA in 2025.
What is an FDA novel drug?
An FDA novel drug is defined as a new drug product containing an active ingredient that has never before been approved or marketed in the United States.
Are biosimilars included?
No, biosimilars are not included in the FDA’s count of “novel drug approvals.”
The FDA strictly differentiates between “novel drugs” and “biosimilars” based on the following criteria:
1.Definition of Novel Drugs: The FDA defines novel drugs as products containing active ingredients that have never before been approved or marketed in the United States. These are typically New Molecular Entities (NMEs) or new therapeutic biologics.
2. Definition of Biosimilars: Biosimilars are biological products that are “highly similar to” and have “no clinically meaningful differences” from an already FDA-approved biological product (the reference product). Because they rely on the safety and effectiveness data of a previously approved ingredient, they do not qualify as “novel.”
