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 currently accurate as of August 28, 2025.

Upcoming FDA Decisions for September 2025

PYRUKYND (sNDA), September 7

  • Agio Pharmaceuticals, Inc.
  • For the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

Ruxolitinib cream (sNDA), September 19

  • Incyte Corporation
  • For the treatment of Atopic Dermatitis in pediatric patients.

Apitegromab (BLA), September 22

  • Scholar Rock Holding Corp
  • For the treatment of spinal muscular atrophy.

SPINRAZA (nusinersen)(sNDA), September 22

  • IONIS Pharmaceuticals Inc
  • For the treatment of spinal muscular atrophy.

SPINRAZA (nusinersen)(sNDA), September 22

  • Biogen Inc.
  • For the treatment of spinal muscular atrophy.

Subcutaneous Keytruda (BLA), September 23

  • Merck & Co Inc.
  • FDA decision on subcutaneous Keytruda across all previously approved solid tumor indications for intravenous Keytruda.

Narsoplimab (Resubmitted BLA), September 25

  • Omeros Corp.
  • For the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Paltusotine (NDA), September 25

  • Crinetics Pharmaceuticals Inc
  • For the treatment and long-term maintenance therapy of acromegaly in adults.

Tolebrutinib (NDA), September 28

  • Sanofi SA
  • For the treatment of non-relapsing secondary progressive multiple sclerosis.

CUTX-101 (NDA), September 30

  • Fortress Biotech Inc.
  • For the treatment of Menkes disease.

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