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FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
FDA 疫苗审批再陷危机：Novavax 新冠针审查超期暴露监管瘫痪
导语： 2025 年 4 月，美国食品药品监督管理局（FDA）未能按期完成对 Novavax 公司针对 JN.1 变种的新冠疫苗审查，距 CBER 主任 Peter Marks 因疫苗政策分歧辞职仅过去三天。这场审批延误不仅暴露 FDA ...
突发！FDA 超半数高层离职，行业命运几何？
在新政府的更迭之下，美国食品药品监督管理局（FDA）正经历着一场前所未有的高层人事动荡。自唐纳德・特朗普再次就职以及罗伯特・F・肯尼迪（Robert F. Kennedy Jr.）执掌美国卫生与公众服务部（HHS）以来，FDA ...
US FDA misses deadline for decision on Novavax's COVID-19 vaccine
The U.S. Food and Drug Administration has missed its deadline for making a decision on traditional approval for Novavax's ...
FDA misses deadline for decision on Novavax's COVID-19 vaccine, source says
The U.S. Food and Drug Administration has missed the deadline for making a decision on Novavax's COVID-19 vaccine, a source ...
Anti-vaccine sentiment may derail vaccines already awaiting FDA approval, experts fear
Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...
阿斯达克财经网8 天
美国FDA疫苗主管辞职 多只医药股价盘前大跌
美国食品药物管理局(FDA)负责疫苗和其他生物药品审批的Peter Marks据报被迫辞职，Moderna(MRNA.US)等疫苗生产商股价暴跌。
Clinical Pain Advisor14 小时
FDA Delays Final Approval of Novavax COVID Vaccine
The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal ...
Health and Me on MSN3 天
FDA Delays Approval Of Novavax COVID-19 Vaccine
The delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s ...
FDA Punts on Major Covid-19 Vaccine Decision After Ouster of Top Official
The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.
FDA delay on Novavax vaccine approval could be bellwether for vaccine sector: BofAS
The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...
Novavax bid for full approval of COVID vaccine stymied by FDA - report
The FDA delays full approval for Novavax's COVID-19 vaccine, citing the need for additional data. Read more here.