19/03/2026 GSK announced FDA approval of linerixibat for adult patients with PBC GSK announced FDA approval of linerixibat for adult patients with PBC ( Ref ) GSK announced that the US FDA had approved Lynavoy (linerixibat; an IBAT inhibitor) for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC) The approval was based on data from the global Phase 3, GLISTEN/ NCT04950127 trial The trial met both primary and key secondary endpoints,

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

24/02/2026 Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis J&J submitted sBLA to the US FDA for approval of IMAAVY® for warm autoimmune hemolytic anemia Abcuro announced topline results from its Phase 2/3 study of ulviprubart in patients with inclusion body myositis ( Ref ) Abcuro announced topline results from its Phase 2/3 MUSCLE/ NCT05721573 study, which evaluated ulviprubart (ABC008; anti-KLRG1) for the tre

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

19/02/2026 AstraZeneca’s Saphnero was approved in Japan for patients with Systemic Lupus Erythematosus AstraZeneca’s Saphnero was approved in Japan for patients with Systemic Lupus Erythematosus ( Ref ) AstraZeneca announced that Japan had approved Saphnero (aniflorumab; anti-IFN1R) subcutaneous injection 120 mg autoinjector for the treatment of patients with Systemic Lupus Erythematosus (SLE) This approval by the Ministry of Health, Labour and Welfare was based on the result

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

12/02/2026 The European Commission approved inebilizumab for the treatment of generalized myasthenia gravis The European Commission approved inebilizumab for the treatment of generalized myasthenia gravis ( Ref ) The European Commission approved Amgen’s Uplizna®(inebilizumab; anti-CD19 mAb) as an add-on treatment to standard therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (M