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 October 2025
Zepzelca (lurbinectedin) (sNDA), October 7, 2025
- Jazz Pharmaceuticals
- In combination with Tezolizumab for first-line maintenance treatment of extensive-stage small cell lung cancer.
ZORYVE cream 0.05% (sNDA), October 13, 2025
- Arcutis Biotherapeutics
- For topical treatment of mild to moderate AD in children 2 to 5 years old
Tezspire (BLA), October 19, 2025
- Amgen
- For patients with chronic rhinosinusitis with nasal polyps.
Epioxa (NDA), October 20, 2025
- Glaukos Corp.
- For treatment of keratoconus.
Blenrep Combinations (BLA), October 23, 2025
- GSK
- In combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for the treatment of multiple myeloma.
Revuforj (sNDA), October 25, 2025
- Syndax Pharma
- For the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia.
Winrevair (sBLA), October 25, 2025
- Merck & Co
- Update to labeling for Winrevair to include the results of the phase 3 ZENITH trial.
Elinzanetant (NDA), October 26, 2025
- Bayer AG
- For moderate-to-severe vasomotor symptoms associated with menopause.
Gazyva (sBLA), October 2025
- Roche Holding AG
- For the treatment of lupus nephritis.
Libtayo (sBLA), October 2025
- Regeneron Pharmaceuticals
- An adjuvant treatment for high-risk cutaneous squamous cell carcinoma
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