(RTTNews) - 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. | Prevents attacks of hereditary angioedema |
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 | Novartis AG | Chronic spontaneous urticaria |
33 | Jascayd | Boehringer Ingelheim | 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 | Bayer HealthCare Pharmaceuticals Inc. | 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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