← FDA DRUG APPROVALS

FDA BLA · BLA761069

IMFINZI

durvalumab

Sponsor: ASTRAZENECA UK LTD

APPLICATION
BLA761069
TYPE
BLA
ORIGINAL APPROVAL
2017-05-01
LATEST ACTION
2026-05-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IMFINZIPrescription
DURVALUMAB 50MG/ML · INJECTABLE · INJECTION

Approval history

2026-05-28Efficacy · Supplement 53 · standard — Letter ↗AP
2025-11-25Efficacy · Supplement 52 · priority — Letter ↗AP
2025-03-28Efficacy · Supplement 50 · priority — Label ↗AP
2025-02-28Efficacy · Supplement 51 · standard — Label ↗AP
2024-12-04Efficacy · Supplement 49 · priority — Label ↗AP
2024-08-15Efficacy · Supplement 43 · standard — Letter ↗AP
2024-07-24Labeling · Supplement 47 · standard — Letter ↗AP
2024-06-14Efficacy · Supplement 45 · standard — Label ↗AP
2024-04-22Labeling · Supplement 48 · standard — Letter ↗AP
2023-12-20Labeling · Supplement 44 · standard — Letter ↗AP
2023-06-16Labeling · Supplement 42 · standard — Letter ↗AP
2022-11-10Efficacy · Supplement 33 · standard — Label ↗AP
2022-10-21Efficacy · Supplement 36 · priority — Letter ↗AP
2022-09-02Efficacy · Supplement 35 · priority — Label ↗AP
2022-05-11Labeling · Supplement 32 · standard — Label ↗AP
2021-07-15Labeling · Supplement 28 · standard — Letter ↗AP
2021-02-19Efficacy · Supplement 29 · priority — Letter ↗AP
2020-11-18Efficacy · Supplement 23 · priority — Label ↗AP
2020-11-18Efficacy · Supplement 24 · priority — Label ↗AP
2020-11-18Labeling · Supplement 25 · standard — Label ↗AP
2020-11-10Labeling · Supplement 12 · standard — Letter ↗AP
2020-06-05Labeling · Supplement 20 · standard — Label ↗AP
2020-03-27Efficacy · Supplement 18 · priority — Label ↗AP
2019-08-26Manufacturing (CMC) · Supplement 16 — Letter ↗AP
2019-07-19Efficacy · Supplement 13 · standard — Label ↗AP
2018-02-16Efficacy · Supplement 2 · priority — Label ↗AP
2017-05-01Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →