29/06/2026 Abbvie received positive CHMP opinion for upadacitinib for the treatment of adults and adolescents with Non-segmental Vitiligo Abbvie received positive CHMP opinion for upadacitinib for the treatment of adults and adolescents with severe alopecia areata Zura Bio exceeded Phase 2 enrollment target for HS and SSc and expanded tibulizumab program Dianthus Therapeutics announced the initiation of a Phase 3 trial of claseprubart in gMG Abivax announced ABETACT maintenan

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

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

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