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

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

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

18/03/2026 J&J announced FDA approval for icotrokinra for adult and pediatric patients with moderate to severe plaque psoriasis J&J announced FDA approval for icotrokinra for adult and pediatric patients with moderate to severe plaque psoriasis ( Ref ) Johnson & Johnson announced that the US FDA had approved ICOTYDE™ (icotrokinra; IL-23 receptor antagonist) for the treatment of adults and pediatric patients aged 12 years and older who weighed at least 40 kg with moderate to s

13/03/2026 Novartis announced FDA approval of secukinumab for pediatric patients with moderate to severe HS Novartis announced FDA approval of secukinumab for pediatric patients with moderate to severe HS ( Ref ) Novartis announced that the US FDA had approved Cosentyx® (secukinumab; anti-IL-17A) for the treatment of pediatric patients aged 12 years and older with moderate to severe hidradenitis suppurativa (HS) The use of Cosentyx in patients aged 12 years and older with mod

06/03/2026 The US FDA approved deucravacitinib for the treatment of patients with active PsA Aisa Pharma announced the results from its Phase 2 trial of AISA-021 in patients with SSc RP The US FDA approved deucravacitinib for the treatment of patients with active PsA ( Ref ) BMS announced that the US FDA had approved Sotyktu® (deucravacitinib; TYK2 inhibitor) for the treatment of adult patients with active psoriatic arthritis (PsA) The approval was based on positive results f

13/02/2026 Novartis announced Phase 3 data in adult patients with IgA nephropathy Novartis announced Phase 3 data in adult patients with IgA nephropathy ( Ref ) Novartis announced final results from its Phase 3 ALIGN/ NCT04573478 study which evaluated Vanrafia (atrasentan; an ETA receptor antagonist) in adult patients with IgA nephropathy (IgAN) The study demonstrated a slowing of kidney function decline in adult patients with IgAN The ALIGN study showed a difference of 2.39

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