European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN) Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025 EU approval is based on the complete data set from the phase-III PROTECT study ST. GALLEN, Switzerland and SAN...
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ST. GALLEN, Switzerland and SAN DIEGO, Calif. — CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio...
ST. GALLEN, Switzerland, and SAN DIEGO, Calif. — CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) support the recent publication of the updated clinical practice guidelines for the treatment of IgA Nephropathy (IgAN), Kidney Disease: Improving Global Outcomes (KDIGO) 2025 clinical practice guideline for the management of IgA Nephropathy and Immunoglobulin...
KING OF PRUSSIA, Penn. — Global biotechnology leader CSL today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the...
SUZHOU, China – CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and Jiangsu Hengrui Pharmaceuticals (“Hengrui”, SHSE: 600276) today announced a strategic partnership and exclusive licensing agreement on anti-CTLA-4 mAb CS1002 in the Greater China region. This strategic partnership marks...
Tsukuba, Japan — Nonfunctional pancreatic neuroendocrine tumors, while rare, are primarily treated through surgery. The presence or absence of lymph node metastasis considerably influences the selection of surgical and other treatment approaches. Particularly controversial is the necessity of surgery for tumors smaller than 2 cm as current clinical guidelines provide...
Longitudinal circulating tumor DNA (ctDNA) analysis can predict disease recurrence and guide adjuvant treatment in patients with resected non-small cell lung cancer (NSCLC), according to a study published in Nature Communications. ctDNA positivity — both after surgery and after adjuvant therapy — was significantly associated with worse recurrence-free survival (RFS), researchers...
SEATTLE – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”) seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L). CTI had previously announced the...
CINCINNATI — Shortly after Ryan Dempster and his wife, Jenny, welcomed daughter Riley into the world on April 1, they learned their daughter suffers from DiGeorge syndrome, a rare congenital disease that prevents her from swallowing and digesting food. Dempster has commuted to Childrens Memorial Hospital over the last seven...
Ryan Dempster, a pitcher for the Chicago Cubs, recently opened up to the Chicago Tribune about his new-born daughter and her fight with DiGeorge Syndrome. In the interview, the professional baseball player admitted that the experience has “been rougher than anything I can imagine.” The syndrome is caused by a...