Mallinckrodt Plc announced that the Cardiovascular And Renal Drugs Advisory Committee of the U.S. FDA voted to recommend approval for its investigational agent terlipressin to treat adults with… read more.
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended eight medicines for approval at its June 2020 meeting.
The Phase III study FIDELIO-DKD evaluating the efficacy and safety of BAY 94 8862 (finerenone), from Bayer, versus placebo when added to standard of care for chronic kidney… read more.
ChemoCentryx, Inc. confirmed that the Company has submitted a New Drug Application (NDA) to the FDA for avacopan for the treatment of patients with ANCA-associated vasculitis. The Company’s… read more.
Mallinckrodt Plc ,announced that the Cardiovascular And Renal Drugs Advisory Committee of the FDA will, as expected, hold a virtual meeting to review data on terlipressin, an investigational… read more.
Mundipharma announces that the European Commission (EC) has approved the extension of the indication of Invokana (canagliflozin) to include important renal outcome data from the landmark Canagliflozin and… read more.
Article written by Bruce Sylvester Patients being treated with angiotensin converting enzyme inhibitors (ACE-i) or angiotensin II receptor blockers (ARBs) for high blood pressure and other conditions appear… read more.
Akebia Therapeutics, Inc.announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD)…. read more.
Boehringer Ingelheim have announced the results of a sub-group analysis from the CAROLINA cardiovascular outcome trial focusing on Asian adults with type 2 diabetes mellitus and elevated cardiovascular… read more.
Ardelyx announced the submission of a New Drug Application (NDA) for Ibsrela (tenapanor) to the FDA for the control of serum phosphorus (hyperphosphatemia) in adult patients with chronic… read more.
Alexion Pharmaceuticals announced that the European Commission has approved Ultomiris (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children… read more.
Hansa Biopharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of… read more.
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