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British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...
2 天
GlobalData on MSNGSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patientsGSK has applied to the US Food and Drug Administration (FDA) to extend use of its respiratory syncytial virus (RSV) vaccine Arexvy to adults under the age of 50 who are at increased risk of the ...
【数据支撑】目前,Arexvy已获美国批准用于预防60岁及以上成年人中RSV相关疾病,同时也适用于50至59岁具有风险因素的成人。此次新申请主要针对年龄段在50岁以下但存在高风险因素的人群。美国FDA预计将在2026年上半年针对该申请做出决策,同时欧 ...
1 天
allAfrica.com on MSNSouth Africa: Government Is Considering Providing a Vaccine to Protect Babies From RSVBlog - A new respiratory syncytial virus vaccine to protect infants from severe illness is available in South Africa's private sector but not yet in public clinics. The country's advisory group on ...
RSV has outstripped severe Covid and flu hospitalisation rates and proved itself more fatal than either of the flu season ...
2 天
Zacks.com on MSNFDA Accepts GSK Filing for Expanded Use of RSV Shot in Younger AdultsFDA accepts GSK's filing to extend Arexvy's RSV vaccine use to high-risk adults under 50, with a decision due in 2026.
Residents in public residential aged care services aged 60 and over can now claim a free vaccine for Respiratory Syncytial ...
Along with Beyfortus (nirsevimab), it is also a potential rival to Pfizer's RSV vaccine Abrysvo, which can be given to women during pregnancy to protect their babies for the first six months after ...
An alternative to the antibody therapies is Pfizer's RSV vaccine Abrysvo, which is approved for maternal immunisation to prevent disease in newborns and infants, as well as for use in older adults ...
The offering, the first IPO this year, attracted more than 32 billion dirhams ($3.5 bln) in demand for 500 million dirhams in shares. GSK seeks FDA nod for expanded use of RSV vaccine in adults ...
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