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Insilico Medicine Announces the Preclinical Candidate for Kidney Fibrosis Discovered Using End-to-End Artificial Intelligence Engine prnasia
August 05, 2021
Insilico Medicine announced that its AI-powered drug discovery platform had delivered the preclinical candidate ("PCC") for kidney fibrosis.
Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis drugs
August 04, 2021
Ardelyx today announced that it has received a Complete Response Letter (CRL) from the FDA regarding the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.
Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis drugs
July 29, 2021
Ardelyx today announced that it received a letter from the U.S. Food and Drug Administration (the "FDA") on July 13, 2021, stating that, as part of its ongoing review of the company's NDA for the control of serum phosphorus in adult patients with CKD.
GSK Announces Positive Headline Results from Five Phase 3 Studies of Daprodustat for Patients with Anemia due to Chronic Kidney Disease drugs
July 23, 2021
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive headline results from five studies of the Phase 3 ASCEND programme, evaluating the efficacy and safety profile of daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase
No Increase in Risk With Dapagliflozin in Patients With Stage 4 CKD drugs
July 22, 2021
For patients with stage 4 chronic kidney disease (CKD), a similar pattern of reduced kidney, cardiovascular, and mortality risks is seen with dapagliflozin versus placebo, with no evidence of increased risks.
Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease drugs
July 20, 2021
FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic kidney disease (CKD) in NDD adult patients.
FDA Vote on Roxadustat in Anemia of Chronic Kidney Disease americanpharmaceuticalreview
July 19, 2021
The FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic kidney disease (CKD) in non-dialysis dependent (NDD) adult ...
Bayer’s Kerendia approved in the US to slow CKD in type 2 diabetes patients pharmatimes
July 15, 2021
Bayer’s first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) Kerendia has received approval in the US to slow chronic kidney disease (CKD) progression in patients with type 2 diabetes (T2D).
CKD-hyperparathyroidism, hyperphosphatemia, hyperkalemia market to grow at 6.9% CAGR by 2030: GlobalData expresspharma
May 19, 2021
Historically, the CKD-HPT, HP, and HK disease space mainly consisted of reformulations of existing drugs and repurposed drugs from other disease markets.
Novo Nordisk’s ziltivekimab hits primary endpoint in CKD trial pharmatimes
May 18, 2021
Novo Nordisk’s investigational interleukin-6 (IL-6) inhibitor ziltivekimab met the primary endpoint in a Phase II trial in people with advanced chronic kidney disease (CKD) and elevated high-sensitivity C-reactive protein (hsCRP), representing high ...

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