New FDA Approved Drugs 2026

Hibsago

bepirovirsen

10/20/2026 To treat chronic hepatitis B virus infection in certain adults without cirrhosis, in combination with existing antiviral therapy

Hovilpri

pritelivir

10/9/2026 To treat adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus infection and have not responded to other therapies

Emcitate

tiratricol

9/28/2026 To treat peripheral thyrotoxicosis in patients with MCT8 deficiency

Atebrioz

zilurgisertib

9/25/2026 To reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressiva

Juvmo

tavapadon

9/25/2026 To treat Parkinson's disease in adults

Lyrfigtu

lirafugratinib

9/23/2026 To adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 gene fusion or other rearrangement

Onswik

insulin efsitora alfa-gobe

9/23/2026 To improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise

Pixclara

floretyrosine F 18

9/11/2026 To use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluations

Isembyld

apitegromab-mstn

9/11/2026 To treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment

Etcamah

camizestrant

9/4/2026 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

Zanvastro

zilganersen

9/3/2026 To treat Alexander disease in pediatric and adult patients

Mimrylo 

rusfertide

8/28/2026 To treat erythrocytosis in adults with polycythemia vera

Lisraya 

brepocitinib

8/27/2026 To treat dermatomyositis in adults

Rasonque 

daraxonrasib

8/26/2026 To treat metastatic pancreatic cancer

Pasatru 

garetosmab-grts

8/19/2026 To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva

Zenbexus 

iberdomide

8/13/2026 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

Tauklarify florquinitau F 18

8/13/2026 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

Orzeyful 

oveporexton

8/5/2026 To treat narcolepsy type 1

Simtriyo 

centanafadine

7/24/2026 To treat attention-deficit hyperactivity disorder

Lytenava 

bevacizumab-vikg

7/24/2026 To treat patients with neovascular (wet) age-related macular degeneration

Jideytro 

zidesamtinib

7/22/2026 To treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitor

Lipfendra 

enlicitide decanoate

7/15/2026 To reduce low-density lipoprotein cholesterol

Revtorpyk 

gedatolisib

7/14/2026 In combination with fulvestran, 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

Trutakna 

atacicept-vymj

7/7/2026 To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression

Lumvoa 

veligrotug-vvze

6/26/2026 To treat thyroid eye disease

Utebzi 

tebipenem pivoxil

6/17/2026 To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options

Ambelvist 

gadoquatrane

6/12/2026 To detect and visualize lesions with abnormal vascularity, in conjunction with MRI

Cypsedo 

cipepofol

5/29/2026 To induce general anesthesia in adults undergoing surgery

Xocova 

ensitrelvir

5/29/2026 To use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19

Zaynich 

cefepime and zidebactam

5/29/2026 To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms

Decnupaz 

pivekimab sunirine-pvzy

5/27/2026 To treat adults with blastic plasmacytoid dendritic cell neoplasm

Hepcludex 

bulevirtide-gmod

5/22/2026 To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis

Baxfendy 

baxdrostat

5/15/2026 To treat hypertension in combination with other antihypertensive drugs

Beqalzi 

sonrotoclax

5/13/2026 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

Veppanu 

vepdegestrant

5/1/2026 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

Idvynso 

doravirine and islatravir

4/20/2026 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

Foundayo 

orforglipron

4/1/2026 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

Awiqli 

insulin icodec-abae

3/26/2026 To improve glycemic control in adults with type 2 diabetes mellitus

Lifyorli 

relacorilant

3/25/2026 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

Avlayah 

tividenofusp alfa-eknm

3/24/2026 To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)

Icotyde 

icotrokinra

3/17/2026 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 Drug Trials Snapshot

Lynavoy 

linerixibat

3/17/2026 To treat cholestatic pruritus associated with primary biliary cholangitis

Yuviwel 

navepegritide

2/27/2026 To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses

Loargys 

pegzilarginase-nbln

2/23/2026 To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction

Bysanti 

milsaperidone

2/20/2026 To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder

Adquey 

difamilast

2/12/2026 To treat mild to moderate atopic dermatitis

Zycubo 

copper histidinate

1/12/2026 To treat Menkes disease

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