The Food and Drug Administration (FDA) provides the Prescription Drug User Fee Act date which marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee meeting is convened to assess drugs or devices under consideration. Presented below is a compiled list of drugs and devices, along with the anticipated decision date.

Upcoming FDA Decisions for June 2025

Clesrovimab, June 10, 2025

  • Merck & Co Inc.
  • FDA decision on the long-acting monoclonal antibody designed to safeguard infants from RSV.

mRNA-1345, June 12, 2025

  • Moderna, Inc
  • FDA decision on the RSV vaccine for high-risk adults 18-59 years old.

UGN-102, June 13, 2025

  • UroGen Pharma Ltd. 
  • FDA decision on UGN-102 for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer.

Sebetrakstat, June 17, 2025

  • KalVista Pharmaceuticals, Inc.
  • FDA decision on the oral on-demand treatment of hereditary angioedema attacks in adult and pediatric patients aged 12 years and older.

Lenacapavir, June 19, 2025

  • Gilead Sciences Inc.
  • FDA decision on the twice-yearly HIV prevention medication.

Dupixent, June 20, 2025

  • Regeneron Pharmaceuticals/Sanofi
  • FDA decision on the bullous pemphigoid treatment for adults.

Shingrix, June 20, 2025

  • GSK plc
  • FDA decision on the prefilled syringe shingles treatment.

Keytruda, June 23, 2025

  • Merck & Co Inc.
  • FDA decision on Keytruda for resectable locally advanced head and neck squamous cell carcinoma. 

Taletrectinib, June 23, 2025

  • Nuvation Bio Inc.
  • FDA decision on the treatment of advanced ROS1-positive non-small cell lung cancer.

Oxylanthanum Carbonate, June 28, 2025

  • Unicycive Therapeutics, Inc.
  • FDA decision on this treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis.

Avutometinib combination, June 30, 2025

  • Verastem, Inc.
  • FDA decision on avutometinib in combination with defactinib for treating recurrent KRAS mutant low-grade serous ovarian cancer.

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