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AstraZeneca’s SLE drug performs well in Phase III trial
pharmaceutical-technology
September 03, 2019
AstraZeneca has announced anifrolumab met the primary endpoint of the Phase III Tulip trial studying 373 systemic lupus erythematosus (SLE) patients.
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FDA fast tracks AstraZeneca's FARXIGA
biospectrumasia
August 29, 2019
FDA Grants Fast Track Designation for FARXIGA in Chronic Kidney Disease
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FDA grants Fast Track designation for Farxiga in chronic kidney disease
worldpharmanews
August 29, 2019
AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Farxiga (dapagliflozin) to delay the progression of renal failure...
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FDA fast tracks AstraZeneca's FARXIGA
biospectrumasia
August 28, 2019
AstraZeneca has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patient
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AstraZeneca agrees to buy US FDA Priority Review Voucher from Sobi
worldpharmanews
August 26, 2019
AstraZeneca announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsidiary of...
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China approves AstraZeneca drug to treat anaemia in CKD patients
biospectrumasia
August 25, 2019
China becomes the first country to approve roxadustat for all chronic kidney disease (CKD) patients with anaemia
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AstraZeneca and FibroGen's roxadustat, not yet filed in U.S., nabs 2nd anemia nod in China
fiercepharma
August 25, 2019
FibroGen has not even filed its AstraZeneca-partnered oral anemia drug roxadustat for U.S. approval. But the collaborators have already scored their second nod for the blockbuster hopeful in China.
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AstraZeneca’s Stage IV Lung Cancer Drug Misses Primary Endpoint
americanpharmaceuticalreview
August 23, 2019
AstraZeneca has announced final overall survival (OS) results from the Phase III NEPTUNE trial, a randomized, open-label, multi-center, global trial of Imfinzi (durvalumab) in combination with tremelimumab ...
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AstraZeneca's Farxiga pads its case for new heart-helping approval
fiercepharma
August 22, 2019
AstraZeneca is still stinging after its SGLT2 diabetes drug Farxiga was waved off by the FDA in Type 1 disease. But here's something that could ease the pain: New outcomes data showing Farxiga cut cardiovascular risks in heart failure patients—with or wit
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AstraZeneca’s Imfinzi fails to meet endpoint in Stage IV NSCLC
pharmaceutical-technology
August 22, 2019
AstraZeneca has announced that Imfinzi (durvalumab), combined with tremelimumab, failed to achieve its primary endpoint in the Phase III NEPTUNE trial of patients with previously-untreated Stage IV non-small cell lung cancer (NSCLC).