Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing

Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets

CStone Pharmaceuticals’ Sugemalimab bags UK nods for Stage III NSCLC

Sugemalimab, developed using CStone’s OmniRat transgenic platform, is a fully human IgG4 monoclonal antibody designed to minimize immunogenicity and toxicity

Lupin receives European Commission approval for biosimilar Ranibizumab

Lonza scales bioconjugate innovation through enhanced synthesis offering

Expansion at the Oss (NL) site adds capacity and R&D capabilities, supporting the development and manufacturing of ADCs and other novel bioconjugates from First-in-Human to commercialization

Roche’s Gazyva hits major milestone in rare kidney disease

Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units

Teva and Sanofi duvakitug Phase 2b data show sustained efficacy in IBD

Duvakitug was well tolerated and safety was consistent with the induction study

STADA & Bio-Thera bag European nod for Gotenfia

Amgen scores EU nod for UPLIZNA in rare autoimmune disease

The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses

GSK’s Nucala receives European Commission approval to treat chronic obstructive pulmonary disease

Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype

Shilpa Medicare & mAbTree Biologics win FDA nod for rare blood cancer therapy

The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options