Browsing Tag
EMA
26 posts
GSK trades near 2,027p as Q1 core EPS rises 9%, full-year 2026 guidance reaffirmed
GSK beat the top line and held guidance, but the harder question is whether Specialty Medicines can keep outrunning the Vaccines and General Medicines drag.
hVIVO (AIM: HVO) wins world-first Phase III whooping cough challenge trial contract with ILiAD Biotechnologies
hVIVO (AIM: HVO) signs its largest human challenge trial contract with ILiAD Biotechnologies for a world-first pivotal Phase III pertussis vaccine study. Read what it means for investors.
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.