FDA Drug Approvals 2026
BETAHow many new drugs has FDA approved in 2026?
FDA has approved 48 novel drugs in 2026, as of November 9, 2026, when it approved Sunharbo (asundexian). Novel drugs are the medicines FDA's drug center counts as new: new molecular entities and new therapeutic biologics. The count is FDA's own list.
Is 2026 a busy year for new drugs?
Yes. By November 13, FDA had approved more novel drugs than at the same point of any year from 2021 to 2025. 2025: 36; 2024: 38; 2023: 47; 2022: 28; 2021: 43. The busiest full year in that period was 2023, with 55.
| Year | By November 13 | Full year |
|---|---|---|
| 2026 | 48 | so far |
| 2025 | 36 | 46 |
| 2024 | 38 | 50 |
| 2023 | 47 | 55 |
| 2022 | 28 | 37 |
| 2021 | 43 | 50 |
Source: FDA's Novel Drug Approvals lists.
Which novel drugs did FDA approve in 2026?
Cancer leads with 10 of the 48, followed by rare genetic diseases (9) and infections (7). 28 are small molecules; the others are 5 proteins or enzymes, 5 peptides, 4 antibodies, 3 imaging agents, 2 oligonucleotides and 1 antibody-drug conjugate. The most recent are Sunharbo (asundexian), Hibsago (bepirovirsen) and Hovilpri (pritelivir).
Cancer (10)
To treat adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 gene fusion or other rearrangement
To treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy
To treat metastatic pancreatic cancer
To be used in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent
To treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitor
In combination with fulvestrant, to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting
To treat adults with blastic plasmacytoid dendritic cell neoplasm
To treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor
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
To treat platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic treatment regimens, at least one of which included bevacizumab
Rare genetic diseases (9)
To treat peripheral thyrotoxicosis in patients with MCT8 deficiency
To reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressiva
To treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment
To treat Alexander disease in pediatric and adult patients
To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva
To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)
To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses
To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction
To treat Menkes disease
Infections (7)
To treat chronic hepatitis B virus infection in certain adults without cirrhosis, in combination with existing antiviral therapy
To treat adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus infection and have not responded to other therapies
To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options
To use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19
To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms
To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis
To treat HIV-1 infection (as a complete regimen) in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine
Heart, blood vessels and metabolism (6)
To reduce the risk of stroke in adults following a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack
To improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise
To reduce low-density lipoprotein cholesterol
To treat hypertension in combination with other antihypertensive drugs
To reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition, in combination with a reduced-calorie diet and increased physical activity
To improve glycemic control in adults with type 2 diabetes mellitus
Brain and mental health (4)
To treat Parkinson’s disease in adults
To treat narcolepsy type 1
To treat attention-deficit hyperactivity disorder
To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder
Immune and inflammatory diseases (4)
To treat dermatomyositis in adults
To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression
To treat moderate-to-severe plaque psoriasis in patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy
To treat mild to moderate atopic dermatitis
Imaging and diagnosis (3)
To use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluations
To be used for positron emission tomography of the brain in adults with cognitive impairment who are being evaluated for Alzheimer disease to identify patients with tau neurofibrillary tangle pathology
Eyes (2)
Anesthesia (1)
Blood disorders (1)
Liver and digestion (1)
What each drug acts on is taken from its FDA label (mechanism of action or microbiology section); for Sunharbo, whose label is not yet published, from FDA's approval announcement.
What counts as a novel drug?
A novel drug is one FDA's Center for Drug Evaluation and Research counts as new: a new molecular entity or a new therapeutic biologic never approved in the US before. FDA publishes the list each year. Vaccines, blood products and cell and gene therapies are approved by another FDA center and are not on it. Generics, new formulations and biosimilars are not novel drugs. The list can still include a medicine already sold in another form when FDA approves it under its own new biologics license, as with Lytenava (bevacizumab-vikg), an eye treatment; bevacizumab has been sold as Avastin since 2004.
What else did FDA approve in 2026?
TheraRadar's FDA data (Drugs@FDA and the Purple Book) records 715 original approvals in 2026 through November 9, 2026: 593 generic drugs (ANDA), 86 new drug applications (NDA) and 36 biologics license applications (BLA). The novel drugs are among the NDAs and BLAs; the rest of those are new formulations and combinations, biosimilars, vaccines, cell and gene therapies and similar products.
All original approvals by year, including generics
What has FDA approved most recently?
Below are the 200 most recent original NDA and BLA approvals and the 200 most recent approvals of any kind, including supplements. Search, or filter by date, application type, company type, disease area and FDA designation.
FDA designation data covers 2016–2025 novel approvals. 2026 approvals show as untagged until FDA publishes the 2026 annual report (~Jan 2027). See full novel approvals dashboard →