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The FDA has accepted for review the sBLA to expand the indication of Arexvy (RSV vaccine, adjuvanted) to adults aged 18 to 49 years who are at increased risk.
The Food and Drug Administration on Wednesday approved Arexvy, the world's first respiratory syncytial virus (RSV) vaccine — a scientific breakthrough 60 years in the making.
London: GSK plc has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend ...
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Zacks Investment Research on MSNFDA Accepts GSK Filing for Expanded Use of RSV Shot in Younger AdultsGSK plc GSK announced that the FDA has accepted its regulatory filing seeking to expand the use of its RSV vaccine, Arexvy, in adults under 50 who are at a higher risk of the disease. A final decision ...
The US FDA approved an RSV vaccine called Arexvy. How effective is it, when will it be available, and who can take it? CNN Medical Analyst Dr. Leana Wen explains.
Up to 10,000 deaths and 160,000 hospitalizations a year are caused by RSV in ... The FDA's decision follows wide majority votes in favor of the safety and efficacy of GSK's Arexvy vaccine at an ...
Health Canada has approved an RSV vaccine for adults over the age of 60 — something many doctors were "happy" to learn. The agency approved GSK’s Arexvy vaccine for the prevention of RSV ...
The Food and Drug Administration Wednesday approved Arexvy, the first vaccine against severe respiratory syncytial virus, more commonly known as RSV. Highly contagious, RSV causes infections of ...
Guillain-Barre syndrome is a rare but serious condition which needs urgent treatment in hospital to prevent it progressing.
The safety and immunogenicity of Arexvy in adults aged 18 to 49 years at increased risk of RSV disease (n=395) was compared with adults aged 60 and older (n=417) in a phase 3b open-label trial ...
Well in advance of the fall and winter RSV season, GSK's vaccine Arexvy is now available in major U.S. retail pharmacies, the company said.
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