Exdensur (depemokimab-ulaa)
New biologic
- Region
- 🇺🇸 US
- Active substance
- depemokimab-ulaa
- Company
- Glaxosmithkline Llc
- Status
- Approved
- FDA approval
- Tue 16 Dec 2025
- Designations
- New biologic
- Application
- BLA761458
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Thu 12 Feb 2026🇪🇺 EU approval (EC decision)
Exdensur (depemokimab) approved in the EU
Marketing authorisation to GlaxoSmithKline Trading Services Limited; Additional monitoring · source
Tue 16 Dec 2025🇺🇸 FDA approval
FDA approves Exdensur (depemokimab-ulaa), a new medicine
Glaxosmithkline Llc; BLA761458; New biologic; injection · source
Thu 11 Dec 2025🇪🇺 CHMP positive opinion
Exdensur (depemokimab): CHMP positive opinion
GlaxoSmithKline Trading Services Limited; Additional monitoring · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.