FDA Alert: FDA Requires Guillain-Barré Syndrome (GBS) Warning …
4 days ago · About Arexvy. Arexvy was initially approved on May 3, 2023, for the prevention of LRTD caused by RSV in individuals 60 years of age and older. Subsequently, FDA has approved the vaccine for use in individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.
FDA Requires Abrysvo, Arexvy RSV Vaccine Labels to Include …
3 days ago · The FDA is now requiring respiratory syncytial virus (RSV) vaccine manufacturers Pfizer and GSK to update their product prescribing information to include the vaccine’s increased risk of subsequent Guillain-Barré syndrome (GBS), according to an FDA news release. 1 “[GBS] is a rare neurological disorder in which a person’s immune system mistakenly attacks part of their peripheral nervous ...
FDA Requires Guillain-Barré Syndrome (GBS) Warning
4 days ago · immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age. About Arexvy
FDA requires Guillain-Barre label warnings for 2 RSV vaccines
2 days ago · The US Food and Drug Administration (FDA) announced yesterday that it has required and approved labeling changes for two respiratory syncytial virus (RSV) vaccines owing to the risk of Guillain-Barre syndrome, a rare neurologic disorder. Drazen Zigic / iStock. The new labeling warnings apply to Pfizer's Abrysvo vaccine and GSK's Arexvy vaccine.
FDA requires Pfizer, GSK to add warning on label of RSV shots
2 days ago · The ruling will affect GSK’s Arexvy and Pfizer’s Abrysvo, both of which were approved by the agency in May of 2023 for adults 60 years or older and realized booming sales in their first year ...
FDA GBS Warning in the Prescribing Info
4 days ago · As part of FDA’s review to support the approval of Arexvy, FDA evaluated safety data from clinical trials in which approximately 16,000 individuals received Arexvy and approximately 13,000 ...
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the...
GSK presents positive data for AREXVY, its respiratory syncytial …
Oct 8, 2024 · GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy and safety of a single dose of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 ...
FDA approves first vaccine for RSV, a moment six decades in the ... - CNN
May 3, 2023 · After a 60-year scientific quest, the world has its first vaccine to protect against respiratory syncytial virus, or RSV – and more are on the way. On Wednesday, the US Food and Drug Administration...
New data for Arexvy, GSK’s respiratory syncytial virus vaccine, …
Oct 24, 2024 · GSK plc (LSE/NYSE: GSK) today announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised.