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

22/06/2026 Merck’s tulisokibart met primary and key secondary endpoints in a Phase 3 study in patiets with moderately to severely active UC FDA and EMA accepted cemdisiran regulatory submissions for review for the treatment of gMG Prolium Biosciences announced milestones in systemic sclerosis and refractory lupus nephritis Merck’s tulisokibart met primary and key secondary endpoints in a Phase 3 study in patiets with moderately to severely active UC (Ref) Merck announced posi

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

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

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