Browsing Tag
EMA
24 posts
GSK’s B7-H3 ADC secures EU orphan drug status as it accelerates global lung cancer trials
GSK’s B7-H3-targeted ADC GSK’227 receives EU Orphan Drug Designation for small-cell lung cancer. Learn how it fits into the company’s expanding global trial program.
Positive CHMP opinion sets stage for GSK’s ready-to-use Shingrix syringe approval in Europe
GSK receives CHMP green light for Shingrix prefilled syringe. Learn how this vaccine format could simplify shingles protection across Europe.
OS Therapies eyes global approvals for OST-HER2 after breakthrough osteosarcoma vaccine trial
OS Therapies’ OST-HER2 cancer vaccine shows strong survival gains in Phase IIb osteosarcoma trial—discover what comes next for global approval.
Zoetis (NYSE: ZTS) gains EMA panel endorsement for Lenivia — Could this reshape the €10bn companion-animal market?
Zoetis (NYSE: ZTS) earns EMA panel endorsement for Lenivia, a long-acting antibody injection for canine osteoarthritis pain. Find out what this means for investors and the veterinary industry.
OS Therapies reports statistically significant 75% two-year survival with OST-HER2, eyes 2026 FDA approval
Find out how OS Therapies’ OST-HER2 achieved 75 % two-year survival in osteosarcoma and could secure FDA approval by 2026.
How Merck’s Keytruda became a global immunotherapy benchmark in cancer treatment
Explore Keytruda’s journey from early PD-1 research to global immunotherapy dominance, with clinical, regulatory, and innovation context shaping cancer care in 2025.
FDA acceptance of Sarfaraz Niazi’s biosimilar petition could reset the economics of monoclonal antibody approvals
FDA accepts Sarfaraz Niazi’s petition to waive costly clinical efficacy studies for monoclonal antibody biosimilars, reshaping drug affordability worldwide.
WuXi Biologics wins EMA approval in Ireland as WuXiUP automation signals new chapter in global biologics manufacturing
WuXi Biologics secures EMA approval in Ireland and achieves WuXiUP automated continuous production, reinforcing global dual sourcing and biomanufacturing innovation.
Biocon (NSE: BIOCON) gains EU nod for Denosumab biosimilars Vevzuo and Evfraxy to target bone health market
Biocon Biologics receives EU approval for Denosumab biosimilars Vevzuo and Evfraxy. Find out how this milestone could reshape its European biosimilars strategy.
Omeros seeks EMA approval for narsoplimab to treat stem cell transplant-related TA-TMA
Omeros Corporation has submitted a Marketing Authorization Application to the EMA for narsoplimab, aiming to treat TA-TMA across Europe. Learn what’s at stake.