15/06/2026 SynAct Pharma reported Phase 2b data of resomelagon in Rheumatoid Arthritis Ultomiris granted Priority Review in the US as treatment for adults with immunoglobulin A nephropathy XBiotech launched Phase 2 trial evaluating vilamakitug for the treatment of active axial spondyloarthritis Spyre announced Part A results from Phase 2 trial of SPY002 in moderate-to-severe UC SynAct Pharma reported Phase 2b data of resomelagon in Rheumatoid Arthritis (Ref) SynAct Pharma AB

02/06/2026 Gilead announced positive phase 3 results for Seladelpar in PBC Vera Therapeutics announced US FDA alignment on an earlier ORIGIN phase 3 eGFR analysis to support potential full approval for atacicept in adults with IgA Nephropathy Rise Therapeutics announced completion of enrollment in the 4-Week dose expansion cohort for R-2487 in RA clinical trial Gilead announced positive phase 3 results for Seladelpar in PBC (Ref) Gilead Sciences announced positive results fro

01/06/2026 Vertex announced US FDA acceptance of BLA for accelerated approval of Povetacicept in IgA nephropathy Abivax announced Phase 3 maintenance results for obefazimod in moderately to severely active UC Vertex announced US FDA acceptance of BLA for accelerated approval of Povetacicept in IgA nephropathy (Ref) Vertex Pharmaceuticals announced that the US FDA had accepted its Biologics License Application (BLA) submission for povetacicept (anti-BAFF and APRIL) in adults w

21/04/2026 FDA accepted application for Roche’s Gazyva for the treatment of SLE Cristcot announced FDA acceptance of NDA for ngHCA for treatment of UC of the Rectum AstraZeneca announced Phase 3 results for ravulizumab for IgA Nephropathy FDA accepted application for Roche’s Gazyva for the treatment of SLE ( Ref ) Roche announced that the US FDA had accepted a supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab; anti-CD20) for the treatment o

20/02/2026 Dr. Reddy’s announced that the US FDA had accepted for review its BLA for a proposed interchangeable biosimilar of ORENCIA® Savara announced that the US FDA had filed for review the BLA for MOLBREEVI for the treatment of autoimmune PAP Dr. Reddy’s announced that the US FDA had accepted for review its BLA for a proposed interchangeable biosimilar of ORENCIA® ( Ref ) Dr. Reddy’s Laboratories announced that the US FDA had accepted for review its Biologics License Appl

10/02/2026 US FDA accepted NDA and granted priority review for Takeda’s oveporexton as a potential first-in-class therapy for Narcolepsy Type 1 Evommune reported positive top-line data from Phase 2a POC trial of EVO301 in moderate-to-severe atopic dermatitis Kincell Bio partnered with Regcell to advance Treg cell therapies into clinical trials for autoimmune diseases US FDA accepted NDA and granted priority review for Takeda’s oveporexton as a potential first-in-class therapy