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 August 2025

LNZ100 (NDA), August 8

  • LENZ Therapeutics, Inc.
  • For the treatment of presbyopia

Ketamine (Resubmitted Abbreviated NDA), August 9

  • PharmaTher Holdings Ltd.
  • For anesthesia, sedation, pain, mental health, and neurological indications

Brensocatib (NDA), August 12

  • Insmed Inc
  • For the treatment of non-cystic fibrosis bronchiectasis

TNX-102 SL (NDA), August 15

  • Tonix Pharmaceuticals Holding Corp.
  • For the management of fibromyalgia

Dordaviprone (NDA), August 18

  • Chimerix, Inc.
  • For the treatment of recurrent H3 K27M-Mutant diffuse glioma

UX111 AAV (BLA), August 18

  • Ultragenyx Pharmaceutical Inc
  • A treatment of Sanfilippo syndrome type A (MPS IIIA)

UX111 (ABO-102) (BLA), August 18

  • ABEONA THERAPEUTICS INC.
  • A treatment for patients with Sanfilippo syndrome type A (MPS IIIA)

Dordaviprone (NDA), August 18

  • Jazz Pharmaceuticals plc
  • For the treatment of recurrent H3 K27M-Mutant diffuse glioma

Vatiquinone (NDA), August 19

  • PTC Therapeutics Inc.
  • For the treatment of children and adults with Friedreich’s ataxia

EYLEA HD Injection 8 mg (sBLA), August 19

  • Regeneron Pharmaceuticals
  • For both the treatment of macular edema following retinal vein occlusion and for broadening the dosing schedule to include every 4-week dosing across approved indications

EYLEA HD Injection 8 mg (sBLA), August 19

  • Bayer AG
  • For both the treatment of macular edema following retinal vein occlusion and for broadening the dosing schedule to include every 4-week dosing across approved indications

Donidalorsen (NDA), August 21

  • Theratechnologies Inc.
  • For the treatment of hereditary angioedema

Donidalorsen (NDA), August 21

  • IONIS PHARMACEUTICALS INC
  • To prevent attacks of hereditary angioedema in adult and pediatric patients 12 years of age and older

ONS-5010 (resubmitted BLA), August 27

  • Outlook Therapeutics, Inc.
  • FDA decision on ONS-5010 for the treatment of wet age-related macular degeneration

PRGN-2012 (BLA), August 27

  • PRECIGEN, INC.
  • FDA decision on PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis

TLX250-CDx (BLA), August 27

  • Telix Pharmaceuticals Limited
  • FDA decision on investigational kidney cancer PET imaging agent TLX250-CDx

FILSPARI (sNDA), August 28

  • Travere Therapeutics Inc
  • FDA decision on sNDA requesting modification of liver monitoring for FILSPARI in IgAN

FILSPARI (sNDA), August 28

  • Ligand Pharmaceuticals Inc
  • FDA decision on sDNA requesting modification of liver monitoring REMS requirement for FILSPARI in IgAN

Rilzabrutinib BTK inhibitor, August 29

  • Sanofi
  • FDA decision on Rilzabrutinib in the US, the EU, and China for potential use in immune thrombocytopenia (ITP)

LEQEMBI subcutaneous autoinjector (BLA), August 31

  • Eisai Co. Ltd.
  • For weekly maintenance dosing for treating early Alzheimer’s

LEQEMBI subcutaneous autoinjector (BLA), August 31

  • Biogen Inc.
  • For weekly maintenance dosing for treating early Alzheimer’s

Leqembi subcutaneous autoinjector (BLA), August 31

  • BioArctic AB
  • For weekly maintenance dosing for treating early Alzheimer’s

Deramiocel (BLA), August 31

  • Capricor Therapeutics, INC.
  • To treat Duchenne muscular dystrophy cardiomyopathy

Sign up for alerts and stay informed on the latest FDA approvals and clinical guidelines.

Copyright © 2025 Guideline Central, all rights reserved.