18/08/2026 Biocon announced US FDA approval of Yesintek® single dose prefilled autoinjector Biocon announced US FDA approval of Yesintek® single dose prefilled autoinjector (Ref) Biocon announced that its US Subsidiary had received supplemental US FDA approval for Yesintek® (ustekinumab-kfce) as a single-dose prefilled autoinjector. The approval covered 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjector presentations. Yesintek® was approved for moderate-to-severe pl

17/07/2026 European Commission approved JASCAYD® as a treatment option for IPF and PPF in the EU Novartis received FDA traditional approval for Fabhalta® for the treatment of primary IgAN European Commission approved JASCAYD® as a treatment option for IPF and PPF in the EU (Ref) Boehringer Ingelheim announced that the European Commission had granted marketing authorization for JASCAYD® (nerandomilast; PDE4B inhibitor) for the treatment of adults with idiopathic pulmonary fibr

18/06/2026 GRI Bio secured FDA Orphan Drug Designation for Tazarotene in Idiopathic Pulmonary Fibrosis GRI Bio secured FDA Orphan Drug Designation for Tazarotene in Idiopathic Pulmonary Fibrosis (Ref) GRI Bio announced that the US FDA had granted Orphan Drug Designation to Tazarotene (GRI-062; oral RARβ/γ-selective agonist) for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The designation marked a significant regulatory milestone and provided a potential pathway to se

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,

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

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

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