相关临床试验
6
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
4
66.7%
招募中
1
16.7%
Unknown
1
16.7%
暂无批准数据
- CROSSJECT secured an additional $11.3 million from BARDA, bringing total funding for ZEPIZURE development to $43.3 million. - The needle-free ZENEO Midazolam auto-injector is advancing toward FDA Emergency Use Authorization and New Drug Application submissions. - Upon FDA approval, BARDA will purchase 360,000 adult and pediatric autoinjectors for $60.8 million for the U.S. Strategic National Stockpile. - The ZENEO platform enables untrained caregivers to deliver emergency epilepsy treatment through clothing without needles.
- CROSSJECT has achieved satisfactory 6-month room temperature stability results for its ZEPIZURE registration batch, a critical milestone in the regulatory submission process for its needle-free epilepsy treatment. - Manufacturing partner EUROFINS is producing additional validation batches to complete the regulatory application, supporting BARDA's timeline for filing an Emergency Use Authorization with the FDA. - If approved, ZEPIZURE could significantly enhance U.S. preparedness against chemical threats while expanding access to the company's innovative ZENEO needle-free auto-injector technology.
