FDA New Drug List 2025 | Novel Drug Approvals for 2025

If you are looking for the New Drug List for 2025, approved by the FDA. We worked on the consolidation of the list with helpful links and company details.

Novel Drug Approvals for 2025

No.	Drug Name/Approval Date	Active Ingredient	Company Name	FDA-approved use
21	Sephience 28.07.2025	Sepiapterin	PTC Therapeutics	To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet
20	Anzupgo 23.07.2025	Delgocitinib	Leo Pharma	To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response
19	Ekterly 03.07.2025	Sebetralstat	KalVista Pharma	To treat acute attacks of hereditary angioedema
18	Zegfrovy 02.07.2025	Sunvozertinib	Dizal Pharma	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	Regeneron Pharmaceuticals Inc	To treat relapsed or refractory multiple myeloma after four prior therapies, including a proteasome inhibitor, immunomodulator, and anti-CD38 antibody.
16	Andembry 16.06.2025	Garadacimab-gxii	CSL Behring LLC	To prevent attacks of hereditary angioedema
15	Ibtrozi 11.06.2025	Taletrectinib	Nuvation Bio Inc	To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer
14	Enflonsia 09.06.2025	Clesrovimab-cfor	Merck	To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season
13	Tryptyr 28/05/2025	Acoltremon	Alcon	To treat the signs and symptoms of dry eye disease
12	Emrelis /14/05/2025	Telisotuzumab vedotin-tllv	Abbvie	To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy
11	Avmapki Fakzynja Co-Pack / 08/05/2025	Avutometinib and Defactinib	Verastem Oncology	To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy
10	Imaavy /29/04/2025	Nipocalimab-Aahu	Johnson&Johnson	To treat generalized myasthenia gravis
9	Penpulimab-kcqx / 23/04/2025	penpulimab-kcqx	Akeso Biopharma Co., Ltd.	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
8	Vanrafia /02/04/2025	Atrasentan	Novartis	To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
7	Qfitlia /28/3/2025	Fitusiran	Sanofi	To prevent or reduce the frequency of bleeding episodes in hemophilia A or BPress Release
6	Blujepa /3/25/2025	Gepotidacin	GSK	To treat uncomplicated urinary tract infections
5	Romvimza / 2/14/2025	Vimseltinib	Deciphera Pharmaceuticals	To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity
4	Gomekli / 2/11/2025	Mirdametinib	SpringWorks	To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
3	Journavx /1/30/2025	Suzetrigine	Vertex Pharmaceuticals	To treat moderate to severe acute painPress Release
2	Grafapex / 1/21/2025	treosulfan	Medac GmbH	For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome
1	Datroway / 1/17/2025	datopotamab deruxtecan-dlnk	AstraZeneca	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

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.

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.