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

  • Gamifant (emapalumab-lzsg) New Indication 
    • For the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
  • Vizamyl (flutemetamol F 18 injection) Expanded Indication
    • To include both quantification of amyloid burden for patients with suspected Alzheimer disease (AD) and use in therapy monitoring.
  • Benlysta (belimumab) New Formulation
    • New autoinjector for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy.
  • Datroway (datopotamab deruxtecan-dlnk) New Indication
    • For the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
  • Dupixent (dupilumab) New Indication
    • For the treatment of adult patients with bullous pemphigoid (BP).
  • Harliku (nitisinone)
    • For the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU).
  • Monjuvi (tafasitamab-cxix)  New Indication 
    • In combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
  • Yeztugo (lenacapavir)  
    • As pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg.
  • Andembry (garadacimab-gxii)  
    • For prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
  • Keytruda (pembrolizumab)  New Indication
    • For the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
  • mRESVIA (respiratory syncytial virus vaccine)  Expanded Indication
    • For adults aged 18-59 who are at an increased risk of contracting severe RSV disease.
  • Zusduri (mitomycin)  
    • For adults with Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC).
  • Brukinsa (zanubrutinib) New Formulation
    • A new tablet formulation for all five approved lymphoma indications.
  • Mavyret (glecaprevir/pibrentasvir) Expanded Indication
    • For the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.
  • Ibtrozi (taletrectinib)
    • For ROS1-positive locally advanced or metastatic non–small cell lung cancer (NSCLC).
  • Xifyrm (meloxicam injection)
    • For the management of moderate-to-severe pain in adults.
  • Widaplik (telmisartan, amlodipine and indapamide)
    • For the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure.
  • Enflonsia (clesrovimab-cfor)
    • For the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season.
  • Sonu Band Expanded Indication
    • For at-home treatment of moderate-to-severe nasal congestion in pediatric patients aged 12 and up.
  • Nubeqa (darolutamide) New Indication
    • For the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC).
  • Xenoview (xenon Xe 129 hyperpolarized) Expanded Indication
    • For use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older.

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