New FDA Drug Approvals 2026

Every new drug and biologic the FDA approved in 2026, with the approval date, the FDA-approved use, the type of review and a page per drug on the pivotal trial, safety signals and alternatives. Updated from FDA's own lists each morning and checked by our editors.

1. October 20262

2. Oct 20

   Hibsago bepirovirsen

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

   Infectious DiseaseOligonucleotidePriority reviewBoxed warningFDA label

3. Oct 9

   Hovilpri pritelivir

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

   Infectious Disease

4. September 202610

5. Sep 28

   Emcitate tiratricol

   To treat peripheral thyrotoxicosis in patients with MCT8 deficiency

   EndocrinologyGeneticsPriority reviewOrphan drugBoxed warningFDA label

6. Sep 25

   Atebrioz zilurgisertib

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

   GeneticsPriority reviewOrphan drugFDA label

7. Sep 25

   Juvmo tavapadon

   To treat Parkinson’s disease in adults

   NeurologyFDA label

8. Sep 23

   Lyrfigtu lirafugratinib

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

   OncologyPriority reviewOrphan drugFDA label

9. Sep 23

   Onswik insulin efsitora alfa-gobe

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

   EndocrinologyTherapeutic biologic5 articlesDrug page →

10. Sep 17

    Fayuvi rebisufligene etisparvovec-hopf

    To treat neurologic manifestations of mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo Syndrome type A) in pediatric patients with preserved neurodevelopmental function

    GeneticsGene therapy

11. Sep 11

    Isembyld apitegromab-mstn

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

    NeurologyTherapeutic biologicPriority reviewOrphan drugFDA label

12. Sep 11

    Pixclara floretyrosine F 18

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

    OncologyRadiologyDiagnostic agentPriority reviewOrphan drugFDA label

14. Sep 4

    Etcamah camizestrant

    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

    OncologyBoxed warning1 articleDrug page →

15. Sep 3

    Zanvastro zilganersen

    To treat Alexander disease in pediatric and adult patients

    NeurologyOligonucleotidePriority reviewOrphan drugFDA label

16. August 202610

17. Aug 28

    Mimrylo rusfertide

    To treat erythrocytosis in adults with polycythemia vera

    HematologyPriority reviewOrphan drugFDA label

18. Aug 27

    Lisraya brepocitinib

    To treat dermatomyositis in adults

    DermatologyPriority reviewOrphan drugBoxed warning1 articleDrug page →

19. Aug 26

    Rasonque daraxonrasib

    To treat metastatic pancreatic cancer

    OncologyPriority reviewOrphan drug4 articlesDrug page →

20. Aug 19

    Genglycos pariglasgene brecaparvovec-opnr

    To reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa)

    GeneticsGene therapyFDA label

21. Aug 19

    Pasatru garetosmab-grts

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

    GeneticsTherapeutic biologicPriority reviewOrphan drugDrug page →

22. Aug 13

    Tauklarify florquinitau F 18

    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

    NeurologyRadiologyDiagnostic agentFDA label

23. Aug 13

    Zenbexus iberdomide

    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

    OncologyPriority reviewOrphan drugAccelerated approvalBoxed warning3 articlesDrug page →

24. Aug 6

    Tudriqev vusolimogene oderparepvec-wtpg

    In combination with nivolumab for treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen

    OncologyGene therapyDrug page →

25. Aug 5

    Orzeyful oveporexton

    To treat narcolepsy type 1

    NeurologyPriority reviewOrphan drug1 articleDrug page →

26. Aug 5

    mFlusiva Influenza Vaccine, mRNA

    Active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine in persons 50 years of age and older. The indication for persons 65 years of age and older is approved under accelerated approval pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) and the regulations for accelerated approval, 21 CFR 601.41

    Infectious DiseaseVaccineAccelerated approval12 articlesDrug page →

27. July 20266

28. Jul 24

    Lytenava bevacizumab-vikg

    To treat patients with neovascular (wet) age-related macular degeneration

    OphthalmologyTherapeutic biologicFDA label

29. Jul 24

    Simtriyo centanafadine

    To treat attention-deficit hyperactivity disorder

    PsychiatryPriority reviewBoxed warningDrug page →

30. Jul 22

    Jideytro zidesamtinib

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

    OncologyOrphan drugFDA label

31. Jul 15

    Lipfendra enlicitide decanoate

    To reduce low-density lipoprotein cholesterol

    CardiologyPriority reviewDrug page →

32. Jul 14

    Revtorpyk gedatolisib

    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

    OncologyPriority reviewFDA label

33. Jul 7

    Trutakna atacicept-vymj

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

    NephrologyTherapeutic biologicPriority reviewFDA label

34. June 20264

35. Jun 30

    Tregzi allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq

    Use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen,for hematopoietic and immunologic reconstitution and to improve chronic graft-versushost disease (cGVHD)-free survival, in the treatment of adults with hematologicalmalignancies

    HematologyCell therapyFDA label

36. Jun 26

    Lumvoa veligrotug-vvze

    To treat thyroid eye disease

    EndocrinologyOphthalmologyTherapeutic biologicPriority reviewFDA label

37. Jun 17

    Utebzi tebipenem pivoxil

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

    Infectious DiseasePriority reviewFDA label

38. Jun 12

    Ambelvist gadoquatrane

    To detect and visualize lesions with abnormal vascularity, in conjunction with MRI

    RadiologyDiagnostic agentOrphan drugBoxed warningFDA label

39. May 20268

40. May 29

    Cypsedo cipepofol

    To induce general anesthesia in adults undergoing surgery

    AnesthesiologyFDA label

41. May 29

    Xocova ensitrelvir

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

    Infectious DiseaseFDA label

42. May 29

    Zaynich cefepime and zidebactam

    To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms

    Infectious DiseasePriority reviewFDA label

43. May 27

    Decnupaz pivekimab sunirine-pvzy

    To treat adults with blastic plasmacytoid dendritic cell neoplasm

    OncologyTherapeutic biologicPriority reviewOrphan drugBoxed warningFDA label

44. May 22

    Hepcludex bulevirtide-gmod

    To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis

    Infectious DiseaseTherapeutic biologicPriority reviewOrphan drugBoxed warningFDA label

45. May 15

    Baxfendy baxdrostat

    To treat hypertension in combination with other antihypertensive drugs

    CardiologyPriority review1 articleDrug page →

46. May 13

    Beqalzi sonrotoclax

    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

    OncologyPriority reviewOrphan drugFDA label

47. May 1

    Veppanu vepdegestrant

    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

    Oncology2 articlesDrug page →

48. April 20263

49. Apr 23

    Otarmeni lunsotogene parvec-cwha

    To treat pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear

    GeneticsGene therapyFDA label

50. Apr 20

    Idvynso doravirine and islatravir

    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

    Infectious Disease2 articlesDrug page →

51. Apr 1

    Foundayo orforglipron

    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

    EndocrinologyBoxed warning6 articlesDrug page →

52. March 20266

53. Mar 26

    Awiqli insulin icodec-abae

    To improve glycemic control in adults with type 2 diabetes mellitus

    EndocrinologyTherapeutic biologicOrphan drug8 articlesDrug page →

54. Mar 26

    Kresladi marnetegragene autotemcel

    To treat pediatric patients with severe leukocyte adhesion deficiency-I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant

    HematologyGeneticsGene therapyDrug page →

55. Mar 25

    Lifyorli relacorilant

    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

    OncologyFDA label

56. Mar 24

    Avlayah tividenofusp alfa-eknm

    To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)

    GeneticsTherapeutic biologicPriority reviewOrphan drugBoxed warningDrug page →

57. Mar 17

    Icotyde icotrokinra

    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

    DermatologyPriority reviewFDA label

58. Mar 17

    Lynavoy linerixibat

    To treat cholestatic pruritus associated with primary biliary cholangitis

    GastroenterologyOrphan drugDrug page →

59. February 20264

60. Feb 27

    Yuviwel navepegritide

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

    EndocrinologyPriority reviewOrphan drugDrug page →

61. Feb 23

    Loargys pegzilarginase-nbln

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

    GeneticsTherapeutic biologicPriority reviewOrphan drugBoxed warningFDA label

62. Feb 20

    Bysanti milsaperidone

    To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder

    PsychiatryBoxed warningFDA label

63. Feb 12

    Adquey difamilast

    To treat mild to moderate atopic dermatitis

    DermatologyFDA label

64. January 20261

65. Jan 12

    Zycubo copper histidinate

    To treat Menkes disease

    GeneticsPriority reviewOrphan drugDrug page →

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For healthcare professionals. A summary of public FDA documents and published trials, not medical advice. Check the full prescribing information before prescribing.