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

  • Besremi (ropeginterferon alfa-2b-njft) New Indication
    • For the treatment of adults with essential thrombocythemia (ET).
  • Mounjaro (tirzepatide) New Indication
    • To lower the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes who are at high risk for these events.
  • Mimrylo (rusfertide)
    • For the treatment of erythrocytosis in adults with polycythemia vera (PV).
  • Bixlenvo (bictegravir/lenacapavir)  
    • For the treatment of HIV in adults who are virologically suppressed.
  • Lisraya (brepocitinib) 
    • For the treatment of adults with dermatomyositis (DM).
  • Tivicay PD (dolutegravir (DTG)) Expanded Indication
    • For use in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor (INSTI)-naïve) weighing at least 2 kg.
  • Rasonque (daraxonrasib)
    • For the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
  • Ziihera (zanidatamab-hrii) New Indication
    • In combination with fluoropyrimidine- and platinum-containing chemotherapy, as first-line treatment of adult patients with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test.
  • Ziihera (zanidatamab-hrii) New Indication
    • In combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as first-line treatment of adult patients with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test.
  • Imaavy (nipocalimab-aahu) New Indication
    • For the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.
  • Genglycos (pariglasgene brecaparvovec-opnr) 
    • In adult and pediatric patients eight years and older with glycogen storage disease type Ia (GSDIa).
  • Pasatru (garetosmab-grts)  
    • To reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).
  • Lerochol (lerodalcibep-liga) Expanded Indication
    • As an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy.
  • Tauklarify (florquinitau F 18 injection)  
    • For positron emission tomography (PET) of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle (NFT) pathology.
  • Zenbexus (iberdomide)  
    • In combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
  • Tudriqev (vusolimogene oderparepvec-wtpg) 
    • In combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.
  • mFLUSIVA (influenza vaccine, mRNA) 
    • For active immunization against seasonal flu in adults aged 50 years and older.
  • Orzeyful (oveporexton) 
    • For the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.

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