A consolidated list of all the FDA approved medications during the month of May 2026.

  • Zaynich (cefepime and zidebactam) 
    • For the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens.
  • Xocova (ensitrelvir) 
    • For post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.
  • Imfinzi (durvalumab) New Indication
    • In combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
  • Decnupaz (pivekimab sunirine-pvzy) 
    • For the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • Linzess (linaclotide) Expanded Indication
    • In pediatric patients 2 years of age and older with functional constipation (FC).
  • Hepcludex (bulevirtide-gmod)  
    • For the treatment of adults living with chronic hepatitis delta virus (HDV) infection.
  • Datroway (datopotamab deruxtecan-dlnk) New Indication
    • For the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
  • Baxfendy (baxdrostat)  
    • For the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.
  • Enhertu (fam-trastuzumab deruxtecan-nxki) New Indication
    • For T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.
  • Enhertu (fam-trastuzumab deruxtecan-nxki) New Indication
    • For T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test.
  • Immgolis Intri (golimumab-sldi) Biosimilar to Simponi Aria
    • As an interchangeable biosimilar biological product to Simponi Aria for adults with severely active rheumatoid arthritis in combination with methotrexate.
  • Immgolis (golimumab-sldi) Biosimilar to Simponi
    • As an interchangeable biosimilar biological product to Simponi for adults with severely active rheumatoid arthritis in combination with methotrexate; and severely active ulcerative colitis
  • Tecentriq (atezolizumab) New Indication
    • As an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay.
  • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) New Indication
    • As an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay.
  • Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate)  
    • For the maintenance treatment of asthma in adults.
  • Fasenra (benralizumab) New Indication  
    • For the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause.
  • Inqovi (decitabine and cedazuridine) New Indication  
    • Plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy.
  • Beqalzi (sonrotoclax) 
    • For the treatment of certain adults with relapsed or refractory mantle cell lymphoma (MCL).
  • Bizengri (zenocutuzumab-zbco) New Indication 
    • For adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy.
  • Ocrevus (ocrelizumab) Expanded Indication 
    • For the treatment of relapsing-remitting multiple sclerosis (RRMS) in pediatric patients 10 years of age and older who weigh 55 pounds (25 kg) or more.
  • Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Expanded Indication 
    • For the treatment of adult patients with generalized myasthenia gravis (gMG).
  • Vyvgart (efgartigimod alfa-fcab) Expanded Indication 
    • For the treatment of adult patients with generalized myasthenia gravis (gMG).
  • Langlara (insulin glargine-aldy) Biosimilar to Lantus
    • As a biosimilar to Lantus, for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
  • Asceniv (immune globulin intravenous, human – slra) Expanded Indication 
    • Expands the treatment of primary humoral immunodeficiency indication to pediatric patients two years of age and older.
  • Jakafi XR (ruxolitinib) New Formulation
    • Extended release formulation for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy.
  • Veppanu (vepdegestrant) 
    • For adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Make sure to sign up for alerts and stay informed on all the latest published guidelines, FDA decisions, and more!