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FDA

Regulatory intelligence
FDAapproval95% confidence

FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer

Source: FDA

Why This Matters

Why this matters: sets a approval precedent in the same sub-indication (asthma) as AstraZeneca; the same agency is already in play for this signal, so precedent weight is higher.

Regulatory Analysis

Supporting Context

Therapeutic area
Respiratory · Asthma
Sub-indication
Asthma

Related signal: FDA Accepts Supplemental Application for Fasenra (Benralizumab) by AstraZeneca

Source

View source document

Related Signal

Open signal — FDA Accepts Supplemental Application for Fasenra (Benralizumab) by AstraZeneca
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