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FDA

Regulatory intelligence
FDAapproval54% confidence

Withdrawn | Cancer Accelerated Approvals

Source: FDA

Why This Matters

Why this matters: sets a approval precedent in the same sub-indication (prostate cancer) as Aragon Pharmaceuticals, Inc..

Regulatory Analysis

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

Supporting Context

Therapeutic area
Oncology · Prostate Cancer
Sub-indication
Prostate Cancer

Related signal: Study on JNJ-56021927 and Abiraterone in Metastatic Prostate Cancer

Source

View source document

Related Signal

Open signal — Study on JNJ-56021927 and Abiraterone in Metastatic Prostate Cancer
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