Biocon Biologics secures Health Canada nod for biosimilars Yesintek, Yesintek IV

Yesintek and Yesintek I.V. are approved for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients

FDA grants priority review to Merck’s KEYTRUDA and KEYTRUDA QLEX combos with Padcev for muscle-invasive bladder cancer

The submissions are supported by data from the Phase 3 KEYNOTE-905 trial

ACG to invest $200 million in US hard-shell capsule manufacturing

The initial $100 million will fund a state-of-the-art hard-shell capsule facility in Atlanta

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study

AstraZeneca’s Imfinzi cuts death risk by 32% in high-risk non-muscle-invasive bladder cancer

Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone

Lundbeck and Contera Pharma join forces to advance RNA therapies for neurological disorders

Contera Pharma will receive an upfront payment and full research funding for each target under investigation

FDA approves Tezspire for chronic rhinosinusitis with nasal polyps

Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation

Roquette opens health and pharma solutions innovation center in Brazil

This new facility strengthens Latin America as a collaborative hub

FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL

Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions

Cupid achieves CE (EU IVDR) certification for pregnancy and syphilis test kits