16/10/2026 US FDA approved Roche’s satralizumab for TED US FDA approved UCB’s zilucoplan autoinjector adults with gMG Novartis halted a mid-stage Fablhalta study in lupus nephritis US FDA approved Roche’s satralizumab for TED (Ref) Roche’s Enspryng® (satralizumab; IL-6R inhibitor) received US FDA approval as the first and only at-home subcutaneous treatment for adults with thyroid eye disease (TED).The approval was based on Ph3, SatraGO-1 and SatraGO -2 studies. SatraGO-2 sho

30/09/2026 Roche’s fenebrutinib received US FDA filing acceptance for RMS and PPMS Merck’s tulisokibart met primary and key secondary endpoints in Ph2b HS study Roche’s fenebrutinib received US FDA filing acceptance for RMS and PPMS (Ref) The US FDA accepted Roche’s NDA for fenebrutinib (BTKi) under Priority Review for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), supported by Ph3 FENhance 1 and 2 RMS studies and the Ph

23/09/2026 Roche’s sefaxersen significantly reduced proteinuria in IgA nephropathy Immunovant’s IMVT-1402 failed to meet the primary endpoint in CLE Roche’s sefaxersen significantly reduced proteinuria in IgA nephropathy (Ref) Roche reported positive prespecified interim results from Ph3 IMAgINATION study of sefaxersen (ASO targeting complement factor B) in adults with primary IgA nephropathy (IgAN). The trial met its primary endpoint, demonstrating statistically significant

18/09/2026 CHMP recommended EU approval of Roche’s Ocrevus for children and adolescents with RMS Novartis’ Cosentyx® received a positive CHMP opinion for PMR Klygefa recommended for EU approval for gMG Alfasigma’s filgotinib received a positive CHMP opinion for axSpA CHMP recommended EU approval of Roche’s Ocrevus for children and adolescents with RMS (Ref) The EMA’s CHMP recommended approval of Ocrevus® (ocrelizumab; CD20 inhibitor) intravenous infusion for patients aged ≥10

10/09/2026 US FDA granted Priority Review to Roche’s Enspryng for MOGAD US FDA granted Priority Review to Roche’s Enspryng for MOGAD. (Ref) Roche announced that the US FDA had granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab; anti- IL-6) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The filing acceptance was based on positive results from the Phase 3, METEOROID study, whi

15/07/2026 FDA granted priority review to Roche’s Gazyva for adults with primary membranous nephropathy InnoCare reported Phase 3 results for soficitinib in atopic dermatitis FDA granted priority review to Roche’s Gazyva for adults with primary membranous nephropathy (Ref) Roche announced that the US FDA had granted priority review to the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab; anti-CD20) for the treatment of primary me

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

22/04/2026 Roche announced Phase 3 data for fenebrutinib in RMS Johnson & Johnson announced Phase 3 data for nipocalimab in gMG Sanofi's Tzield approved in the US to delay the onset of stage 3 T1D in young children Roche announced Phase 3 data for fenebrutinib in RMS (Ref) Roche announced new positive data from the Phase 3 FENhance 1 and 2 studies, Which investigated fenebrutinib (BTK inhibitor) for the treatment of patients with Relapsing Multiple Sclerosis (RMS). FENhance 1

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

02/03/2026 Lynk Pharmaceuticals announced positive Phase 3 data for zemprocitinib in moderate-to-severe atopic dermatitis Abbive announced topline results form a Phase 3 study that evaluated resankizumab subcutaneous induction in patients with CD Roche announced positive results from a Phase 3 study that evaluated fenebrutinib in patients with RMS Sanofi's rilzabrutinib earned orphan drug designation in Japan for IgG4-related disease Lynk Pharmaceuticals announced positive Ph

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