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AstraZeneca’s Farxiga (dapagliflozin) has been granted fast track designation from the US Food and Drug Administration (FDA) for its use in reducing the risk of heart failure.
More from Pharmaceutical Business Review:
Healio News 09/16/2019 11:01
The FDA has granted fast track designation to the SGLT2 inhibitor dapagliflozin for reducing the risk for cardiovascular death or worsening heart failure among adults with heart failure with reduced or preserved ejection fraction, according to a press release from AstraZeneca ...
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Business Wire 09/16/2019 07:30
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Heart failure affects approximately 64 million people worldwide, and about half will die within five years of diagnosis.
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pharmaphorum 09/16/2019 05:27
The FDA has granted Fast Track designation on the bases of data from two phase 3 trials, DAPA-HF and DELIVER, investigating Farxiga in patients with heart failure with reduced ejection and preserved ejection fraction, respectively.
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PR Newswire 09/12/2019 10:16
It causes high blood pressure in the pulmonary arteries, which results in failure of the right ventricle of the heart," noted cardiologist and V-Wave Chief Medical Officer, William T. Abraham , MD.
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SoniVie, a company based in Israel, won FDA Breakthrough Device Designation for its TIVUS intravascular ultrasound system for patients suffering from pulmonary arterial hypertension (PAH.
More from Medgadget - Internet Journal of Emerging Medical Technologies:
GlobeNewswire 09/02/2019 12:00
The positive feedback from the FDA regarding our clinical development plan to advance firibastat into Phase III trials in the United States represents a key milestone in the execution of our strategic plan as presented in April 2018.
More from GlobeNewswire: 08/29/2019 15:00
On Wednesday, the agency said it is likely that the risk is much lower than this "worst-case scenario" as most patients likely "received much smaller amounts of the impurity," because not all blood pressure medications are tainted, the AP reported.
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FDA clears Biobeat's wearable watch and patch for non-invasive cuffless monitoring of blood pressure.
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