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BLA761495 ()

New biologicPriority review
Region
🇺🇸 US
Company
Merck Sharp And Dohme Llc
Status
Approved
FDA approval
Wed 15 Oct 2025
Designations
New biologic, Priority review
Application
BLA761495
Official record
www.accessdata.fda.gov

Regulatory milestones

Wed 15 Oct 2025🇺🇸 FDA approval

FDA approves BLA761495, a new medicine

Merck Sharp And Dohme Llc; BLA761495; New biologic, Priority review · 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.