19/05/2026 UCB announced week 16 data from the BE BOLD study in PsA UCB announced week 16 data from the BE BOLD study in PsA (Ref) UCB announced data from the Phase 3, BE BOLD/ NCT06624228 study which compared the efficacy of BIMZELX®(bimekizumab; Anti-IL-17A and anti-IL-17F) versus SKYRIZI®(risankizumab; Anti-IL-23) after 16 weeks of treatment in participants with active psoriatic arthritis (PsA). The study met its primary endpoint of belimumab superiority in ACR50 at Week 1

18/05/2026 FDA approved IMMGOLIS™ and IMMGOLIS INTRI™ biosimilars for RA and UC FDA approved IMMGOLIS™ and IMMGOLIS INTRI™ biosimilars for RA and UC (Ref) Accord Biopharma announced that the US FDA had approved IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi) biosimilar for rheumatoid arthritis (RA) and ulcerative colitis (UC). IMMGOLIS™ (golimumab-sldi), a biosimilar to Simponi® (golimumab), was approved for the treatment of adult patients with moderately to s

14/05/2026 Filing of Gazyva for additional indication of Idiopathic Nephrotic Syndrome Filing of Gazyva for additional indication of Idiopathic Nephrotic Syndrome (Ref) Chugai Pharmaceutical and Nippon Shinyaku announced that Chugai had filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for Gazyva® (obinutuzumab; anti-CD20) for intravenous infusion 1000 mg for an additional indication of idiopathic nephrotic syndrome (INS). The filing was ba

13/05/2026 Qureight to support Mediar Therapeutics’ Phase 2 trial of MTX-474 in diffuse cutaneous Systemic Sclerosis Qureight to support Mediar Therapeutics’ Phase 2 trial of MTX-474 in diffuse cutaneous Systemic Sclerosis (Ref) Qureight, an imaging CRO and Mediar Therapeutics announced that Qureight’s AI-powered 3D quantitative imaging analytics platform and services will be used to support Mediar’s Phase 2, EncompaSSc trial evaluating MTX-474 (a first in class human mAb, th

11/05/2026 Fate Therapeutics showcased FT819 clinical activity in SLE without the use of conditioning chemotherapy at the 2026 ASGCT Annual Meeting Fate Therapeutics showcased FT819 clinical activity in SLE without the use of conditioning chemotherapy at the 2026 ASGCT Annual Meeting (Ref) Fate Therapeutics showcased FT819 (an Off-the-shelf CD19 CAR T-cell therapy) which was being investigated in a Phase 1/ NCT06308978 study in patients with moderate-to-severe systemic lupu

10/05/2026 MoonLake Immunotherapeutics announced a positive outcome from its final Pre-BLA meeting with the US FDA for sonelukimab in HS MoonLake Immunotherapeutics announced a positive outcome from its final Pre-BLA meeting with the US FDA for sonelukimab in HS (Ref) MoonLake Immunotherapeutics announced a positive outcome from its final pre-BLA meeting with the US FDA on the Hidradenitis suppurativa (HS) program for its Nanobody® sonelokimab (SLK; an inhibitor of IL-17A and

08/05/2026 BMS received EU approval of deucravacitinib for the treatment of active PsA in adults Argenx announced US approval expanding VYVGART and VYVGART Hytrulo for use in all adult patinets living with gMG BMS received EU approval of deucravacitinib for the treatment of active PsA in adults (Ref) BMS announced that the European Commission had granted approval to Sotyktu (deucravacitinib; TYK2 inhibitor), alone or in combination with methotrexate, for the treatment of acti

07/05/2026 Incyte announced long-term data from Phase 3 study of ruxolitinib cream in adult patients with AD Incyte announced long-term data from Phase 3 study of ruxolitinib cream in adult patients with AD (Ref) Incyte announced final 24-week data from its Phase 3, TRuE-AD4 study which evaluated the efficacy and safety of Opzelura® (ruxolitinib) cream in adults with moderate atopic dermatitis (AD) who had an inadequate response, intolerance or contraindication to topical cor

06/05/2026 InflaRx announced advancement of Izicopan in AAV and select renal diseases SynAct Pharma completed dosing for the last patient in Phase 2b study for RA InflaRx announced advancement of Izicopan in AAV and select renal diseases (Ref) InflaRx announced that it intended to develop izicopan (an oral C5a receptor inhibitor) in ANCA-Associated Vasculitis (AAV). InflaRx was conducting Phase 2 planning for izicopan in AAV and was evaluating the feasibility of multiple deve

05/05/2026 J&J announced Phase 2b data from two studies in IBD J&J announced Phase 3 results for guselkumab in CD Avalo Therapeutics announced positive Phase 2 results for abdakibart in HS J&J announced Phase 2b data from two studies in IBD (Ref) Johnson & Johnson announced data from two Phase 2b studies, DUET-UC/ NCT05242484 and DUET-CD/ NCT05242471, which evaluated JNJ-4804 (IL-23 and TNF-α) in patients with moderately to severely active ulcerative colitis (UC) and Crohn’s

04/05/2026 Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC (Ref) Mirum Pharmaceuticals announced that the primary endpoint was met in the Phase 2b, VISTAS study, which evaluated volixibat (an IBAT inhibitor) in patients with primary sclerosong cholangitis (PSC). Volixibat demonstrated a statistically significant and clinically m

03/05/2026 UCB announced agreement to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers UCB announced agreement to acquire Candid Therapeutics, building upon its existing immunology pipeline with novel T-cell engagers (Ref) UCB announced that it had signed a definitive agreement to acquire Candid Therapeutics, a privately held clinical-stage biotechnology company developing novel T-cell engagers for the treatment of autoimm

01/05/2026 UCB announced acquisition of IMIDomics’ patient insight business, strengthening capabilities in IMIDs UCB announced acquisition of IMIDomics’ patient insight business, strengthening capabilities in IMIDs (Ref) UCB and IMIDomics announced that UCB had acquired the Patients Insights Business of IMIDomics, gaining access to multi-omic datasets for immune mediated inflammatory diseases (IMIDs). The Patient Insight Business enhanced UCB’s ability to identify novel drug

30/04/2026 Merck announced first patient dosed in Phase 3 study with enpatoran for lupus patients with active skin manifestations Merck announced first patient dosed in Phase 3 study with enpatoran for lupus patients with active skin manifestations (Ref) Merck announced that the first patient had been dosed in the Phase 3 program, ELOWEN-1/ NCT07332481and ELOWEN-2/ NCT07355218, evaluating enpatoran (TLR 7/8 inhibitor) in people living with lupus who experience active skin man

29/04/2026 Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA Hutchmed announced NDA acceptance in China with Priority Review status and Breakthrough Designation for sovleplenib for the treatment of wAIHA (Ref) Hutchmed announced that the New Drug Application (NDA) for sovleplenib (a spleen tyrosine kinase) for the treatment of adult patients with warm antibody autoimmune hemolytic ane

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

24/04/2026 Sanofi’s tolebrutinib was recommended for EU approval to treat secondary progressive multiple sclerosis without relapses Sanofi’s tolebrutinib was recommended for EU approval to treat secondary progressive multiple sclerosis without relapses (Ref) Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Cenrifki (tolebrutinib; BTK inhibitor) in the EU for the

23/04/2026 Cumberland Pharmaceuticals announced strategic transaction to integrate commercial business with Apotex Cumberland Pharmaceuticals announced strategic transaction to integrate commercial business with Apotex (Ref) Cumberland Pharmaceuticals announced it had entered into an agreement with an affiliate of Apotex to integrate their branded US business. Under the terms of the agreement, Apotex was to acquire Cumberland's line of branded pharmaceuticals for cash conside

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