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FDA

Regulatory intelligence
FDAapproval54% confidence

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

Source: FDA

Why This Matters

Why this matters: sets a approval precedent in the same sub-indication (lung cancer) as Merck.

Regulatory Analysis

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.

Supporting Context

Therapeutic area
Oncology · NSCLC
Sub-indication
Lung Cancer

Related signal: Merck and Gilead Discontinue Phase 3 Study of Trodelvy and KEYTRUDA in NSCLC

Source

View source document

Related Signal

Open signal — Merck and Gilead Discontinue Phase 3 Study of Trodelvy and KEYTRUDA in NSCLC
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