BioSpace News Archive

CorMedix Inc. (Nasdaq: CRMD) today announced that the U.S. Food and Drug Administration (FDA) has approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC).

Avation Medical, Inc., an innovative neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions, today announced the publication of safety and efficacy results from a multi-center study, “FREEOAB”, for its novel Vivally System in Urology, a leading, peer–reviewed journal for urologists.

A new study published in Nature, conducted by the Accelerating Medicines Partnership, reports on the identification of new subtypes of rheumatoid arthritis by analyzing molecular patterns in biopsies from patient joints.

Certa Therapeutics (Certa) announces the presentation of results of its Phase 2 clinical trial of FT011 in patients with scleroderma at ACR Convergence 2023, the annual scientific meeting of the American College of Rheumatology being held in San Diego, California (10 – 15 November 2023).

Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.

Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, today announced that the management team will present at the 35th Annual Piper Sandler Healthcare Conference on Wednesday, November 29, 2023.

CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that the management team will present at the 35th Annual Piper Sandler Healthcare Conference on Wednesday, November 29, 2023.

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that The Lancet Neurology published a preliminary data analysis from the ASPIRO trial, evaluating the safety and efficacy of investigational AT132 (resamirigene bilparvovec), an adeno-associated viral vector (AAV) gene replacement therapy designed to deliver a functional human MTM1 gene for the treatment of pediatric patients with X-linked myotubular myopathy (XLMTM).

Kyverna Therapeutics, Inc. (Kyverna) today announced the publication in The Lancet Neurology of a Letter to the Editor by a group of German investigators describing the first case of treatment using KYV-101 in a 33 year-old patient with severe, treatment-refractory, anti-acetylcholine receptor auto-antibody positive, generalized myasthenia gravis (MG), who was treated on a named patient basis outside of a clinical trial setting.

RemeGen Co., Ltd. is invited to present telitacicept Phase III Clinical Trial Results for Rheumatoid Arthritis Patients in a Late-Breaking Abstract Oral Presentation Session by the American College of Rheumatology.