IgA Nephropathy
Jul 21, 2026
Novartis Secures FDA Traditional Approval for Fabhalta in Primary IgAN; GSK Reports Mixed Phase III Results for Camlipixant in Refractory Chronic Cough; Merck Secures FDA Approval for LIPFENDRA; Innovent Reports Positive Phase II Results for Soficinib in Vitiligo; Lilly Signs Deal to Acquire AtaiBeckley for Mental Health Therapies
Novartis Wins FDA Traditional Approval for Fabhalta to Treat Primary IgAN Novartis announced that the US Food and Drug Administration (FDA) has granted traditional approval to Fabhalta (iptacopan) for slowing the progression of kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) wh...
Read More...
Jul 17, 2026
Top FDA Approvals to Watch in H2 2026: Regulatory Decisions Poised to Transform the Pharmaceutical Landscape
Summary H2 2026 is expected to be a highly active FDA regulatory period, with decisions spanning oncology, nephrology, infectious diseases, neurology, hematology, and rare diseases, reflecting greater therapeutic diversity beyond oncology dominance. Key innovation trends include first- and best-in-class biol...
Read More...
Jul 07, 2026
Novartis to Acquire Myricx Bio; Roche’s Divarasib Tops Approved KRAS G12C Inhibitors in Phase III NSCLC Trial; Otsuka Reports Positive Two-Year Phase 3 Results for VOYXACT in IgA Nephropathy; Revolution Medicines Reports Early Clinical Data for Zoldonrasib Combination Regimens at ESMO GI 2026; Can-Fite Completes Patient Enrolment for Interim Analysis in Pivotal Phase 3 Psoriasis Trial
Novartis to Acquire Myricx Bio to Expand Next-Generation ADC Portfolio Novartis has signed an agreement to acquire Myricx Bio, a privately owned biotechnology company based in the UK that is developing a novel class of antibody-drug conjugates (ADCs) featuring N-myristoyltransferase inhibitor (NMTi) payloads. ...
Read More...
Jun 16, 2026
Ultomiris Receives US Priority Review for Adult IgA Nephropathy Treatment; FDA Approves WELIREG Plus KEYTRUDA or KEYTRUDA QLEX for Adjuvant Treatment of Select ccRCC Patients; Jazz Pharmaceuticals Highlights Phase 3 LAGOON Trial Update for Zepzelca® in Second-Line SCLC; Novartis’ delpacibart braxlosiran (del-brax) Achieves Primary Biomarker Endpoint in Phase I/II FSHD Study; Takeda’s Zasocitinib Tops Deucravacitinib in Phase 3 Psoriasis Trial, Setting a New Benchmark for Oral Therapies; IMAAVY Demonstrates Clinically Meaningful and Sustained Hemoglobin Responses in Pivotal wAIHA Study
Ultomiris Secures Priority Review Status in the US for Adult IgA Nephropathy Alexion, AstraZeneca Rare Disease announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for Ultomiris as a potential treatment for adults with Immunoglobulin A Nephropat...
Read More...
Jun 09, 2026
Roche Expands Pipeline Through Global Bexobrutideg Partnership with Nurix Therapeutics; Incyte to Acquire Vega Therapeutics; Tango Therapeutics Unveils Promising Pancreatic Cancer Data with Vopimetostat–Daraxonrasib Combination; Otsuka Announces Encouraging 12-Month eGFR Outcomes from Phase 3 VISIONARY Study of VOYXACT in IgAN; Innovent Biologics Unveils Phase 3 DREAMS-3 Findings for First Approved GCG/GLP-1 Dual Receptor Agonist
Roche and Nurix Therapeutics Partner to Advance BTK Degrader Bexobrutideg Roche has entered into an exclusive licensing and collaboration agreement with Nurix Therapeutics to jointly develop and commercialize bexobrutideg (NX-5948), Nurix’s investigational Bruton’s Tyrosine Kinase (BTK) degrader. Through this pa...
Read More...
May 04, 2026
Deep Dive Into World Congress of Nephrology 2026 (WCN’26): Transforming Kidney Care and Innovation
The World Congress of Nephrology 2026 (WCN’26) is the flagship event of the International Society of Nephrology (ISN). The Congress was co-hosted by the Japanese Society of Nephrology (JSN) and the Asian Pacific Society of Nephrology (APSN). This conference marked a pivotal moment in the evolution of kidney disease...
Read More...
Feb 17, 2026
Roche’s GAZYVA/GAZYVARO Achieves Key Phase III Success in Primary Membranous Nephropathy; Novartis’ VANRAFIA Slows Kidney Function Decline in Phase III IgA Nephropathy Trial; PTC Therapeutics Shares Latest Regulatory Developments for Translarna; BridgeBio’s Oral Infigratinib Achieves Key Body Proportionality Improvements in Phase 3 Achondroplasia Trial; Upstream Bio’s Verekitug Achieves Key Endpoints in Phase 2 Trial for Severe Asthma Treatment
Roche Reports Positive Phase III Data for GAZYVA/GAZYVARO in Primary Membranous Nephropathy Roche has reported highly encouraging results from the Phase III MAJESTY study, which evaluated the efficacy and safety of GAZYVA/GAZYVARO (obinutuzumab) in adults suffering from primary membranous nephropathy (PMN). PMN ...
Read More...
Sep 02, 2025
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s; Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy; Vanda Pharmaceuticals’ VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera; Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss; Sanofi’s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb), a once-weekly 360 mg subcutaneous autoinjector designed for maintenance do...
Read More...
Jun 20, 2025
Advancements in IgA Nephropathy (IgAN) Treatment: From Standard-of-care (SoC) to Emerging Therapies
IgA Nephropathy (IgAN): Pathogenesis and the Need for Targeted Therapies IgA nephropathy is a complex autoimmune disorder characterized by the accumulation of galactose-deficient IgA1 antibodies in the glomeruli, triggering a cascade of immune responses that ultimately lead to chronic kidney damage. Driven by a ...
Read More...
Apr 08, 2025
Amgen’s UPLIZNA Wins First FDA Nod for IgG4-Related Disease; Aldeyra Gets FDA CRL for Reproxalap in Dry Eye; Novartis’ Vanrafia Snags Accelerated FDA OK for IgAN Proteinuria; Biogen’s BIIB080 Earns Fast Track for Alzheimer’s; Epicrispr’s EPI-321 Cleared by FDA for FSHD
Amgen’s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease Amgen announced that the FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition that can affec...
Read More...
-Agonist.png "Toll-like Receptors Agonist")
