The U.S. Food and Drug Administration (FDA) in 2025 approved 46 novel drugs, including 34 new molecular entities (NMEs) and 12 biologics.The approved drugs treated indications ranging from advanced or refractory breast and lung cancers, systematic issues like angioedema, neuropathy, and microangiopathy, and mutational disorders such as haemophilia and proteinuria. Of the approved novel drugs, 11 received accelerated approval, 18 received a fast track designation, and 21 were granted a priority review. Additionally, 20 were first-in-class drugs for specific indications, and 23 were for rare disease indications.
S.No
Drug Name
Developer
Indication
1
Datroway
Daiichi Sankyo Co Ltd
HR-positive, HER2-negative, unresectable or metastatic breast cancer
2
Grafapex
Medexus Pharmaceuticals Inc
Preparative regimen for allogenic haematopoetic stem cell transplants to treat acute myeloid leukemia and myelodysplastic syndrome
3
Journavx
Vertex Pharmaceuticals Inc
Moderate-to-severe pain
4
Gomekli
SpringWorks Therapeutics Inc.
Neurofibromatosis type-1, symptomatic plexiform neurofibromas
5
Romvimza
Deciphera Pharmaceuticals
Symptomatic tenosynovial giant cell tumours
6
Blujepa
GSK plc
Complicated urinary tract infections
7
Qfitlia
Alnylam Pharmaceuticals
Prevents or reduces frequency of bleeding episodes in Haemophilia A or B
8
Vanrafia
Novartis AG
Decreases proteinuria in adults with primary immunoglobulin A neuropathy
9
penpulimab-kcqx
Akeso, Inc
Recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) in adults
10
Imaavy
Johnson & Johnson
Generalized myasthenia gravis
11
Avmapki Fakzynja Co-Pack
Verastem Inc.
KRAS-mutated recurrent low-grade serious ovarian cancer (LGSOC) in adults
12
Emrelis
AbbVie Inc
Locally advanced or metastatic non-small cell lung cancer (NSCLC) with high c-Met protein expression
13
Tryptyr
Alcon AG
Signs and symptoms of dry eye disease
14
Enflonsia
Merck & Co Inc
Prevents respiratory synctial virus (RSV) lower respiratory tract disease in neonates and infants
15
Ibtrozi
Nuvation Bio Inc.
Locally advanced or metastatic ROS-1 positive non-small cell lung cancer (NSCLC)
16
Andembry
CSL Ltd.
Prevents attacks of hereditary angioedema
17
Lynozyfic
Regeneron Pharmaceuticals, Inc.
Relapsed or refractory multiple myeloma after 4 prior lines of therapy
18
Zegfrovy
Dizal Pharmaceuticals Co. Ltd.
Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor exon 20 insert mutation
19
Ekterly
KalVista Pharmaceuticals
Acute attacks of hereditary angioedema
20
Anzupgo
LEO Pharma
Moderate-to-severe chronic hand edema
21
Sephience
PTC Therapeutics Inc.
Hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria
22
Vizz
Lenz Therapeutics Inc.
Presbyopia
23
Modeyso
Jazz Pharmaceuticals PLC
Diffuse midline glioma with H3K27M mutation
24
Hernexeos
Boehringer Ingelheim
Unresectable or metastatic non-small cell lung cancer (NSCLC) tumours with HER2 tyrosine kinase domain activation mutation
25
Brinsupri
Insmed Inc
Non-cystic fibrosis bronchiectasis
26
Dawnzera
Ionis Pharmaceuticals Inc.
27
Wayrilz
Sanofi SA
Persistent or chronic immune thrombocytopenia
28
Keytruda Qlex
Merck & Co. Inc.
Solid tumour indications in adult and pediatric patients
29
Forzinity
Stealth BioTherapeutics Inc.
Improves muscle strength
30
Inluriyo
Eli Lilly & Company
Receptor positive, human epidermal growth factor receptor 2 negative, estrogen receptor 1 mutation advanced or metastatic breast cancer
31
Palsonify
Crinetics Pharmaceuticals Inc.
Acromegaly in adults
32
Rhapsido
Chronic spontaneous urticaria
33
Jascayd
Idiopathic pulmonary fibrosis
34
Lynkuet
Bayer HealthCare Pharmaceuticals Inc.
Moderate-to-severe vasomotor symptoms due to menopause
35
Kygevvi
UCB
Thymidine kinase 2 deficiency
36
Komzifti
Kura Oncology Inc.
Relapsed or refractory acute myeloid leukemia with susceptible nucleophosmin 1 mutation
37
Redemplo
Arrowhead Pharmaceuticals Inc.
Reduces triglycerides in adults with familial chylomicronemia syndrome
38
Hyrnuo
Locally advanced or metastatic non-small cell lung cancer (NSCLC) tumours with HER2 tyrosine kinase domain activating mutation
39
Voyxact
Otsuka Pharmaceuticals Co. Ltd.
Reduces proteinuria in adults with primary immunoglobulin A neuropathy
40
Lerochol
LIB Therapeutics Inc.
Reduces low-density lipoprotein cholesterol in adults with hypercholestremia, including heterozygous familial hypercholestremia
41
Nuzolvence
Innoviva Specialty Therapeutics
Uncomplicated urogenital gonorrhea caused by Neserria gonorrheae
42
Cardamyst
Milestone Pharmaceuticals Inc.
Episodes of paroxysmal supreventricular techycardia
43
Exdensur
GSK plc (GlaxoSmithKline)
Severe asthma characterized by eosinophilic phenotype
44
Myqorzo
Cytokinetics Incorporated
Symptomatic obstructive hypertrophic cardiomyopathy
45
Yartemlea
Omeros Corporation
Haematopoetic stem cell transplant-associated thrombotic microangiopathy
46
Nereus
Vanda Pharmaceuticals Inc.
Vomiting associated with motion
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