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May 13, 2026
NewAmsterdam Pharma said regulatory decisions on obicetrapib in Europe, the UK and Switzerland remain expected in 2H26. PREVAIL interim analysis is planned for 4Q2026, with a result expected in 1Q2027.
Apr 23, 2026
The FDA accepted Hansa Biopharma’s BLA for imlifidase and set a PDUFA action date of Dec. 19, 2026. The filing is backed by Phase 3 ConfIdeS data showing statistically significant efficacy.
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.
Mar 19, 2026
Bayer's Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline in non-diabetic chronic kidney disease patients. The drug met its primary endpoint with improved eGFR slope over 32 months, marking its fifth consecutive positive Phase III trial. Bayer plans to submit the data to the FDA for label expansion into non-diabetic CKD.
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 06, 2026
The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.
Mar 04, 2026
New research demonstrates blood-based biomarkers can predict testicular cancer recurrence and treatment outcomes, while separate study reveals long-term health risks vary by chemotherapy regimen in survivors.
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
Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.
Feb 18, 2026
The FDA has approved pitolisant tablets for treating cataplexy in pediatric patients aged 6 and older with narcolepsy, making it the only non-scheduled therapy approved for both pediatric and adult narcolepsy patients with or without cataplexy.
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 13, 2026
Real-world study finds SGLT2 inhibitors reduce chronic kidney disease and acute kidney injury risk more effectively than GLP-1 receptor agonists in patients with type 2 diabetes, with greatest benefits in those without preexisting kidney disease.
Dec 22, 2025
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
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.
