30/06/2026 FDA granted priority review to Roche’s satralizumab as a treatment option for TED FDA granted priority review to Roche’s satralizumab as a treatment option for TED (Ref) Roche announced that the US FDA had accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED). The filing acceptance was based on results from the two randomized phase 3, SatraGO-1/ NCT0598

26/06/2026 SKYRIZI® received US FDA approval for pediatric psoriatic disease Viridian Therapeutics announced US FDA approval and commercial launch of Lumvoa™ for Thyroid Eye Disease SKYRIZI® received US FDA approval for pediatric psoriatic disease (Ref) AbbVie announced that the US FDA had approved SKYRIZI® (risankizumab-rzaa; IL-23 inhibitor) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic ther

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

08/06/2026 Telitacicept received NMPA conditional approval for the treatment of IgA Nephropathy in China Telitacicept received NMPA approval for the treatment of Sjögren’s disease in China Alvotech announced FDA acceptance of a BLA for AVT16, a proposed interchangeable biosimilar to Entyvio® Telitacicept received NMPA conditional approval for the treatment of IgA Nephropathy in China (Ref) Vor Bio and RemeGen Co. announced that China’s National Medicinal Products Administrati

05/06/2026 Otsuka presented interim Phase 3 data showing sibeprenlimab preserved kidney function over 12 months in IgAN InnoCare presented Phase 2b results for Orelabrutinib in patients with SLE at EULAR-2026 Otsuka presented interim Phase 3 data showing sibeprenlimab preserved kidney function over 12 months in IgAN (Ref) Otsuka Pharmaceutical announced that VOYXACT® (sibeprenlimab-szsi; APRIL inhibitor) preserved kidney function compared to placebo over 12 months in adults w

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

28/05/2026 Zenas BioPharma announced submission of BLA to US FDA for Obexelimab in IgG4-RD Innocare announced the acceptance of the NDA for Orelabrutinib in Primary ITP in China Zenas BioPharma announced submission of BLA to US FDA for Obexelimab in IgG4-RD (Ref) Zenas BioPharma announced the submission of its Biologics License Application (BLA) to the US FDA for obexelimab (CD19 and FcγRIIb) in Immunoglobulin G4-Related Disease (IgG4-RD). The BLA submission was supported by

28/04/2026 AbbVie submitted an application to the FDA for upadacitinib for adults and adolescents with Severe AA InnuCare announced that the first patient had been dosed in a Phase 3 trial of orelabrutinib for SLE AbbVie submitted an application to the FDA for upadacitinib for adults and adolescents with Severe AA (Ref) AbbVie announced that it had submitted an application to the US FDA for RINVOQ® (upadacitinib; JAK inhibitor) for the treatment of adult and adolescent patien

27/04/2026 AbbiVe submitted a regulatory application to the FDA for risankizumab for adults with moderately to severely active CD Saphnelo was approved in the US for subcutaneous self-administration for the treatment of SLE Novartis announced that remibrutinib had received EU approval for the treatment of chronic spontaneous urticaria The FDA granted Priority Review for nipocalimab for the treatment of wAIHA AbbiVe submitted a regulatory application to the FDA for risankizuma

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

07/04/2026 Climb Bio announced FDA Fast Track Designation for budoprutug for the treatment of pMN Climb Bio announced FDA Fast Track Designation for budoprutug for the treatment of pMN ( Ref ) Climb Bio announced that the US FDA had granted Fast Track Designation to budoprutug (anti-CD19 mAb) for the treatment of primary membranous nephropathy (pMN) Brudoprutug was being studied in Phase 2 patinets with pMN The company anticipated initial data from Phase 2 study in H2 2026

16/03/2026 Spyre Therapeutics announced results from the Phase 2 rheumatoid arthritis sub-study InnoCare Pharma announced that ICP-538 had been approved for clinical trials in China and had completed dosing of the first subject Lilly announced Phase 3 results of lebrikizumab in pediatric patients with moderate-to-severe AD Sun Pharma announced US FDA had accepted for review the sBLA for tildrakizumab for the treatment of adults with active PsA Spyre Therapeutics announced res

10/03/2026 Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD ( Ref ) Redx Pharma announced that the US FDA had granted fast track designation to RXC008 (a GI-restricted pan-ROCK inhibitor) for the treatment of patients with fibrostenotic crohn’s disease (CD) Lisa Anson, CEO, Redx Pharma: “ Redx have been working closely with the FDA and the STAR consortium to define the regulatory

26/02/2026 GSK’s linerixibat accepted for Priority review by China’s NMPA in patients with PBC Boehringer acquired an exclusive license for a novel oral therapeutics program for immune diseases from Sitryx Argenx announced topline results from Phase 3 trial of VYVGART in Ocular myasthenia gravis Soligenix received a positive opinion from the EMA on its request for orphan drug designation for SGX945 for the treatment of behçet's disease GSK’s linerixibat accepted for Priority

24/02/2026 Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis J&J submitted sBLA to the US FDA for approval of IMAAVY® for warm autoimmune hemolytic anemia Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis ( Ref ) Abcuro announced topline results from its Phase 2/3 MUSCLE/ NCT05721573 study, which evaluated ulviprubart (ABC008; anti-KLRG1) for the tre

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

16/02/2026 Roche announced positive Phase 3 results for Gazyva/Gazyvaro in primary membranous nephropathy Roche announced positive Phase 3 results for Gazyva/Gazyvaro in primary membranous nephropathy ( Ref ) Roche announced positive results from the Phase 3 MAJESTY/ NCT04629248 study which evaluated the efficacy and safety of Gazyva/Gazyvaro (obinutuzumab; anti-CD20) in patients with primary membranous nephropathy The study met its primary endpoint of complete remission at t

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