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US Food and Drug Administration

FDA approved AstraZeneca’s Brilinta to reduce the risk of stroke

1 min read

The FINANCIAL — AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institutes of Health Stroke Scale score ≤5) or high-risk transient ischaemic attack (TIA). The approval by the US Food and Drug Administration (FDA) was based on positive results from the THALES Phase III trial that showed aspirin plus Brilinta 90mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischaemic stroke or TIA.1 The decision follows the Priority Review designation granted by the FDA in…

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FDA approved AstraZeneca’s Brilinta to reduce the risk of stroke

1 min read

The FINANCIAL — AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institutes of Health Stroke Scale score ≤5) or high-risk transient ischaemic attack (TIA). The approval by the US Food and Drug Administration (FDA) was based…

FDA fully approved Venclexta combinations for acute myeloid leukaemia

2 mins read

The FINANCIAL — Roche today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive…