Urovant Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for vibegron, a beta-3 adrenergic agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA submission includes data from an extensive clinical development program involving over 4000 patients with…
Full study results will be presented at an oral plenary session at the OxalEurope International Congress on Tuesday, March 31, 2020.
GlaxoSmithKline announced positive results from the phase 3 BLISS-LN trial of belimumab for the treatment of active lupus nephritis in adult patients.
The FDA has accepted for review the New Drug Application (NDA) for veverimer (TRC101; Tricida) for the treatment of metabolic acidosis in patients with chronic kidney disease (CKD).
The primary end point was radiographic progression-free survival (rPFS), defined as the time from randomization to radiographic disease progression at any time or death within 24 weeks after drug discontinuation.
The FDA has granted Fast Track designation for itolizumab (EQ001; Equillium) for the treatment of lupus nephritis.
The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to ATM-AVI (aztreonam and avibactam; Allergan) for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). Aztreonam is a monobactam that has activity against metallo β-lactamase…
The FDA has approved Ultomiris (ravulizumab-cwvz; Alexion) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adult and pediatric patients aged 1 month and older.
Rybelsus is the first glucagon-like peptide (GLP-1) available in a tablet formulation that is approved for once daily use
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to obinutuzumab (Genentech), a CD20-directed cytolytic antibody, for the treatment of adults with lupus nephritis. The designation was based on data from the phase 2 NOBILITY study that compared the efficacy and safety of obinutuzumab, in combination with mycophenolate mofetil (MMF) or mycophenolic acid…
