London-listed AstraZeneca (LSE: AZN) has been handed a new approval from the US Food and Drug Administration for Faslodex (fulvestrant) as a monotherapy in breast cancer.
The decision, which is based on data from the Phase III FALCON trial, comes hot on the heels of another regulatory green light for the drug, from the European Medicines Agency.
The approval expands the label for the estrogen receptor targeting hormonal therapy, to include certain patients with the hormone-receptor positive (HR+) type of breast cancer.
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