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FDA Grants Breakthrough Device Designation to AWAK Technologies’ Wearable Peritoneal Dialysis Device

SINGAPORE, Jan. 11, 2019 /PRNewswire/ — AWAK Technologies (AWAK), a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and …

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Researchers Discover Kidney Disease Gene Affects More Populations Than Previously Thought

New York, NY (December 27, 2018) — In the largest population genomics investigation to date, a team of researchers at the Icahn School of Medicine at Mount Sinai, Stanford University, and the University of Colorado have discovered that kidney disease risk variants of the gene APOL1, previously known to affect …

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FibroGen Announces Positive Topline Results from Three Phase 3 Trials of Roxadustat for Treatment of Anemia in Patients with CKD

SAN FRANCISCO, Dec. 20, 2018 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ:FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, today announced that roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity (HIF-PHI), met all primary efficacy endpoints in the three global pivotal Phase 3 trials conducted …

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FDA Approves AstraZeneca’s Lokelma for Treatment of Adults with Hyperkalemia

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition characterized by high levels of potassium in the blood (greater than 5.0 mEq/L).1,2,4 The risk of hyperkalemia increases …

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FDA Approves Otsuka’s Jynarque as the First Treatment to Slow Kidney Function Decline in Patients at Risk of Rapidly Progressing ADPKD

TOKYO–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a genetic disease with consequences that can lead …

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Boehringer Ingelheim and Lilly Collaborate with University of Oxford to Investigate Empagliflozin in Chronic Kidney Disease

INGELHEIM, Germany & INDIANAPOLIS, Ind.–(BUSINESS WIRE)–Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced an academic collaboration with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with …

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FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor for the Treatment of IgA Nephropathy

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway …

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Baxter and Mayo Collaborate to Transform Patient Care

DEERFIELD, Ill. & JACKSONVILLE, Fla.–(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), a global medical products company, and Mayo Clinic today announced a new research and development collaboration to advance innovation across a spectrum of therapeutic areas where there are high unmet patient needs. The collaboration agreement will bring together the clinical and …

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FDA Approves Sanofi’s Thymoglobulin for Prevention of Acute Kidney Transplant Rejection

BRIDGEWATER, N.J., April 24, 2017 /PRNewswire/ — Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved Thymoglobulin® [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in patients receiving a kidney transplant. Kidney disease is the ninth leading cause …

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FDA Rejects AstraZeneca’s Hyperkalemia Drug

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate). Sodium zirconium cyclosilicate is being developed for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. Hyperkalaemia is …

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