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

20/04/2026 Nektar Therapeutics announced results from Phase 2b study for rezpegaldesleukin in severe-to-very severe AA Biogen entered into agreement with TJ Biopharma for felzartamab in the Greater China Region Nektar Therapeutics announced results from Phase 2b study for rezpegaldesleukin in severe-to-very severe AA ( Ref ) Nektar Therapeutics announced topline results from its Phase 2b REZOLVE-AA/ NCT06340360 study, which evaluated rezpegaldesleukin (IL-2 pathway agonist) f

15/04/2026 Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP Savara announced that the US FDA had extended the review period for molgramostim BLA in autoimmune PAP ( Ref ) Savara announced that the FDA had extended the review period for the malgramostim ( Molgramostim Inhalation Solution ) BLA in autoimmune pulmonary alveolar proteinosis (Autoimmune PAP) by three months The Agency was reviewing the molgramostim BLA under Pr

13/04/2026 Saphnelo® subcutaneous approved in Canada for the treatment of SLE Saphnelo® subcutaneous approved in Canada for the treatment of SLE ( Ref ) Astrazeneca announced that Health Canada had granted a Notice of Compliance (NOC) for Saphnelo ® (anifrolumab; type 1 IFNR) for subcutaneous self-administration via a single-use autoinjector in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) in addition to standard therapy The approval by

07/04/2026 Climb Bio announced FDA Fast Track Designation for budoprutug for the treatment of pMN Climb Bio announced FDA Fast Track Designation for budoprutug for the treatment of pMN ( Ref ) Climb Bio announced that the US FDA had granted Fast Track Designation to budoprutug (anti-CD19 mAb) for the treatment of primary membranous nephropathy (pMN) Brudoprutug was being studied in Phase 2 patinets with pMN The company anticipated initial data from Phase 2 study in H2 2026

06/04/2026 Tenvie Therapeutics announced dosing of first subject in Phase 1 trial of TNV262 Amgen announced topline results from Phase 3 teprotumumab in active TED Tenvie Therapeutics announced dosing of first subject in Phase 1 trial of TNV262 ( Ref ) Tenvie Therapeutics announced the first subject dosed in a Phase 1 clinical study evaluating TNV262 (a fully CNS-penetrant small molecule inhibitor targeting NLRP3) for the treatment of cardiometabolic diseases, including obesi

02/04/2026 Immunovant announced Phase 3 results for batoclimab in thyroid eye disease Immunovant announced Phase 3 results for batoclimab in thyroid eye disease ( Ref ) Immunovant announced topline results from its two Phase 3 (GO) studies that evaluated batoclimab (an FcRn antagonist) for the treatment of adult patients with active, moderate-to-severe thyroid eye disease (TED) The studies failed to meet their primary endpoint of achieving ≥2mm proptosis responder rate at We

01/04/2026 Alkermes announced initiation of Phase 3 Brilliance studies evaluating alixorexton for NT1 and NT2 Alkermes announced initiation of Phase 3 Brilliance studies evaluating alixorexton for NT1 and NT2 ( Ref ) Alkermes announced the initiation of the Phase 3 Brilliance studies program, which evaluated the safety and efficacy of alixorexton (ALKS 2680; selective OX2R agonist) for the treatment of adult patients with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) T

31/03/2026 Galapagos and Gilead entered into a binding agreement to collaborate on advancing a T cell engager program for autoimmune diseases Galapagos and Gilead entered into a binding agreement to collaborate on advancing a T cell engager program for autoimmune diseases ( Ref ) Galapagos and Gilead Sciences entered into a binding collaboration agreement to co-develop gamgertamig (OM336; BCMAxCD3 T cell engager) originally developed by Ouro Medicines targeting deep B-cell de

30/03/2026 Aurinia Pharmaceuticals announced acquisition of Kezar Life Sciences Savara announced EMA validation of MAA for MOLBREEVI in autoimmune PAP Aurinia Pharmaceuticals announced acquisition of Kezar Life Sciences ( Ref ) Aurinia Pharmaceuticals entered into a definitive merger agreement to acquire Kezar life sciences for $6.955 per share in cash, plus one non-transferable Contingent Value Right (CVR), which represents the right to receive: Potential payments from the

28/03/2026 Biogen announced Phase 2 results for litifilimab for CLE Results from Sanofi’s Phase 3 studies in AD were presented AAD Alumis announced Phase 3 data for envudeucitinib for plaque psoriasis Incyte announced Phase 3 data for povorcitinib for HS Biogen announced Phase 2 results for litifilimab for CLE ( Ref ) Biogen announced positive results from part A of its Phase2/3 AMETHYST/ NCT05531565 study, which evaluated litifilimab (BDCA2) for the treatment of patients w

26/03/2026 UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG Soligenix received orphan drug designation from the European Commission for SGX945 for the treatment of Behçet's Disease UCB received positive CHMP opinion for zilucoplan in EU for adults with gMG ( Ref ) UCB announced that the European Medicines Agency’s CHMP had issued a positive opinion to expand the use of ZILBRYSQ® (zilucoplan; C5 inhibitor), with a new pre-filled pen device as an add

23/03/2026 Gilead Sciences to acquire Ouro Medicines to advance first in class T cell engager program for autoimmune diseases Apogee Therapeutics announced Phase 2 results of zumilokibart in Moderate-to-Severe AD Galapagos and Gilead in advanced discussions to collaborate on advancing first in class T cell engager program for autoimmune diseases Kali Therapeutics announced a worldwide exclusive license agreement with Sanofi for KT501 for autoimmune diseases Gilead Sciences to

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,

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

17/03/2026 Celltrion announced that the tocilizumab SC formulation was now commercially available to patients in the US Celltrion announced that the tocilizumab SC formulation was now commercially available to patients in the US ( Ref ) Celltrion announced that AVTOZMA® (tocilizumab; IL-6 receptor antagonist) subcutaneous (SC) formulation was now commercially available to patients in the United States AVTOZMA® was among the first wave of tocilizumab biosimilars with both intr

16/03/2026 Spyre Therapeutics announced results from the Phase 2 rheumatoid arthritis sub-study InnoCare Pharma announced that ICP-538 had been approved for clinical trials in China and had completed dosing of the first subject Lilly announced Phase 3 results of lebrikizumab in pediatric patients with moderate-to-severe AD Sun Pharma announced US FDA had accepted for review the sBLA for tildrakizumab for the treatment of adults with active PsA Spyre Therapeutics announced res

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

11/03/2026 UCB announced Phase 3 results of bimekizumab versus Risankizumab in a head-to-head study in PsA UCB announced Phase 3 results of bimekizumab versus Risankizumab in a head-to-head study in PsA ( Ref ) UCB announced positive topline results from its Phase 3 BE BOLD/ NCT06624228 head-to-head study, which evaluated BIMZELX®▼(bimekizumab; a selective inhibitor of IL-17A and IL-17F) versus SKYRIZI® (risankizumab; a selective inhibitor of IL-23) for the treatment of adu

10/03/2026 Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD Redx’s RXC008 granted US FDA fast track designation for fibrostenotic CD ( Ref ) Redx Pharma announced that the US FDA had granted fast track designation to RXC008 (a GI-restricted pan-ROCK inhibitor) for the treatment of patients with fibrostenotic crohn’s disease (CD) Lisa Anson, CEO, Redx Pharma: “ Redx have been working closely with the FDA and the STAR consortium to define the regulatory