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FDA BLA · BLA761342

TALVEY

talquetamab

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761342
TYPE
BLA
ORIGINAL APPROVAL
2023-08-09
LATEST ACTION
2026-05-06
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TALVEYPrescription
TALQUETAMAB-TGVS 40MG/ML · INJECTABLE · INJECTION
TALVEYPrescription
TALQUETAMAB-TGVS 3MG/1.5ML(2MG/ML) · INJECTABLE · INJECTION

Approval history

2026-05-06REMS · Supplement 19 — Letter ↗AP
2026-03-05REMS · Supplement 20 — Letter ↗AP
2025-10-02Labeling · Supplement 16 — Label ↗AP
2025-08-19REMS · Supplement 15 — Letter ↗AP
2024-12-02REMS · Supplement 12 — Letter ↗AP
2024-07-02REMS · Supplement 5 — Letter ↗AP
2024-02-20REMS · Supplement 4 — Letter ↗AP
2023-11-16REMS · Supplement 1 — Letter ↗AP
2023-08-09Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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