隶属于 BRACCO SPA
相关临床试验
40
39 进行中
药物批准
65
批准总数
监管机构
4
监管机构数
成立时间
N/A
进行中（未招募）
38
95.0%
已完成
1
2.5%
尚未招募
1
2.5%
- The European Medicines Agency's CHMP adopted a positive opinion on December 11, 2025, recommending extension of Vueway (gadopiclenol) approval to pediatric patients below 2 years of age, including neonates. - Vueway is a macrocyclic gadolinium-based contrast agent with the highest longitudinal relaxivity among approved GBCAs, delivering comparable diagnostic efficacy at half the gadolinium dose of gadobutrol. - The recommendation addresses a critical need for reduced gadolinium exposure in vulnerable populations whose brains and body tissues are still maturing, with unknown long-term effects of retained gadolinium. - The positive opinion was based on results from study GDX-44-015, reinforcing Vueway's established safety and diagnostic performance profile in this special patient population.
- The FDA has expanded the indication for Bracco's Max 3™ syringeless MRI injector to include use with VUEWAY® (gadopiclenol) injection Imaging Bulk Package in 30 mL and 50 mL formats. - The Max 3™ is the first and only syringeless MRI injector available in the U.S. market, designed for precise, efficient, and hygienic contrast delivery. - VUEWAY® provides effective contrast enhancement at half the gadolinium dose compared to other macrocyclic GBCAs, with over three million injections administered at more than 902 customer sites. - The multi-dose IBP packaging enables delivery of multiple single doses from one container, reducing material waste and improving workflow efficiency.
• Blue Earth Therapeutics has secured $76.5M in Series A financing to advance its radiohybrid PSMA-targeted radioligand therapies. • The funding will support Phase II studies of Lutetium (177-Lu) rhPSMA-10.1 and Actinium (225-Ac) rhPSMA-10.1 for prostate cancer. • Blue Earth aims to compare its rhPSMA candidates with first-generation prostate cancer radioligand therapies to improve patient outcomes. • The investment reflects growing interest in the theranostics market, projected to reach $39 billion by 2032, driven by radiopharmaceuticals.
