A consolidated list of all the FDA approved medications during the month of July 2025.

  • Empaveli (pegcetacoplan) New Indication
    • For the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
  • Sephience (sepiapterin)
    • For the treatment of children and adults living with phenylketonuria (PKU).
  • Skytrofa (lonapegsomatropin-tcgd) New Indication
    • For the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production.
  • Doptelet / Doptelet Sprinkle (avatrombopag) Expanded Indication
    • For the treatment of thrombocytopenia in pediatric patients one year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a prior therapy - also includes a new sprinkle formulation for children under six years old.
  • Anzupgo (delgocitinib)
    • For adults with moderate to severe chronic hand eczema (CHE) who have not responded adequately to prior topical corticosteroids or for whom corticosteroid use is not advisable.
  • Shingrix (zoster vaccine recombinant, adjuvanted) New Formulation
    • A new prefilled syringe presentation, for the prevention of herpes zoster.
  • Kirsty (insulin aspart-xjhz) Biosimilar to NovoLog
    • Biosimilar to and interchangeable with Novolog, to improve glycemic control in adults and pediatric patients with diabetes mellitus.
  • Kerendia (finerenone)  
    • To treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%.
  • SIR-Spheres Y-90 (Yttrium-90 microspheres) Expanded Indication
    • For the treatment of patients with unresectable hepatocellular carcinoma (HCC).
  • Ekterly (sebetralstat)
    • For the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
  • Lynozyfic (linvoseltamab-gcpt)
    • To treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.
  • Zegfrovy (sunvozertinib)
    • For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

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