Related coverage linked through entity extraction aliases.
May 05, 2026
Vertex completed the rolling BLA submission for povetacicept in IgA nephropathy after positive Phase 3 RAINIER interim data. The company plans to use a Priority Review Voucher to accelerate FDA review.
Apr 14, 2026
The FDA granted full approval to Filspari to reduce proteinuria in patients aged eight and older with FSGS without nephrotic syndrome. The decision was based on Phase III DUPLEX data versus irbesartan.
Apr 03, 2026
Final phase 3 trial results show atrasentan (Vanrafia®) provides significant long-term kidney function benefits in IgA nephropathy patients, with a 2.59 mL/min/1.73m² eGFR improvement versus placebo. Earlier phase 2 data demonstrated the drug reduces proteinuria by 30.7% when added to standard background therapy. The drug's manufacturer plans to seek traditional FDA approval in 2026 based on these findings.
Apr 02, 2026
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
Mar 18, 2026
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
Mar 14, 2026
New research demonstrates RNA therapies can enhance heart regeneration after injury, while RNA biomarkers improve prediction of cardiovascular complications in chronic kidney disease patients.
Mar 09, 2026
New research demonstrates machine learning can optimize drug dosing, identifies biomarkers of treatment response, and validates prognostic criteria for long-term kidney survival in pediatric lupus nephritis patients.
Mar 02, 2026
Phase III trial demonstrates belzutifan plus lenvatinib significantly improved progression-free survival versus cabozantinib in previously treated renal cell carcinoma patients, while neoadjuvant studies show promise for locally advanced disease.
Feb 25, 2026
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
Feb 19, 2026
Novartis commits $23 billion to U.S. manufacturing expansion with new facilities in North Carolina, California, and Florida, while advancing its immunoglobulin A nephropathy drug portfolio with positive Phase III results for Vanrafia.
Feb 16, 2026
Novartis announced final Phase III ALIGN trial results showing Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy, with a 2.39ml/min/1.73m² eGFR difference versus placebo at week 136.
Feb 16, 2026
Genentech's Phase III MAJESTY study showed Gazyva achieved statistically significant complete remission rates versus tacrolimus in primary membranous nephropathy, a chronic autoimmune kidney disease affecting over 96,000 people in the U.S.
Feb 16, 2026
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
Feb 16, 2026
The Phase III MAJESTY study met its primary endpoint, showing significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy.
Feb 13, 2026
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
