FDA Approval for BENLYSTA issued to GLAXOSMITHKLINE LLC
FDA approved SUPPL-38 label update for BENLYSTA (belimumab) BLA 761043 on 10/30/2026; no new indication or pricing detail disclosed.
What this release says
The FDA recorded a supplement approval (SUPPL-38) for BENLYSTA, belimumab injection, under GlaxoSmithKline LLC's biologic license application 761043, with an action date of 10/30/2026. The filing lists only the approval date and an updated label, and does not describe what the supplement changed. Shareholders can read the label to see the scope of the update.
Key figures
- Application number
- 761043
- Action date
- 10/30/2026
- Belimumab strength
- 200MG/ML
Written by Quantisnow AI from this release. Not financial advice.
Key terms
- Biologic License Application (BLA):
- The FDA application type used to approve biological medicines such as antibody drugs.
- Supplement:
- A later change to an already-approved application, such as a label update or new indication.
FAQ
What did the FDA approve for GlaxoSmithKline's BENLYSTA on 10/30/2026?
The filing records a supplement approval designated SUPPL-38 under BLA 761043, but it does not state what the change covered. The updated label is linked in the filing.
Is the BENLYSTA label the same as before this approval?
The filing lists a new label for SUPPL-38 and earlier labels for prior supplements, but it does not summarize the differences between them.
Historical context for GSK
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- Market cap
- 30-day
- Sector
- Health Care
- Industry
- Biotechnology: Pharmaceutical Preparations
- Listed since
- 2022
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