GSK, Pfizer RSV Shots Required to Carry Guillain-Barré Syndrome ...
1 day ago · The RSV vaccine space is dominated by GSK and Pfizer, with the former being the undisputed leader. Arexvy was approved in May 2023 — one month ahead of Pfizer’s Abrysvo—and raked in nearly $1.6 billion by the end of 2023. Abrysvo’s 2023 earnings, in comparison, sat at $515 million.
FDA requires Pfizer, GSK to add warning on label of RSV shots
1 day ago · The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning about the risk of developing Guillain-Barré syndrome (GBS), a rare ...
GSK, Pfizer RSV shots must warn about rare paralysis risk
1 day ago · Pfizer and GSK vaccines will now be required to carry warnings that they may be tied to an increased risk of a rare neurological side effect. Photo by Beata Zawrzel/NurPhoto via Getty Images Rankings
GSK, Pfizer RSV Shots to Warn About Rare Neurological Disorder
2 days ago · GSK Plc and Pfizer Inc.’s vaccines for a common respiratory virus must carry warnings that they may be tied to an increased risk of a rare neurological side effect that can lead to paralysis ...
FDA Requires Guillain-Barré Syndrome (GBS) Warning
3 days ago · Abrysvo was initially approved on May 31, 2023, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
FDA adds warning to RSV shots from GSK, Pfizer
2 days ago · GSK’s and Pfizer’s vaccines for respiratory syncytial virus must carry labels warning of a possible increased risk of a rare neurological disorder, the Food and Drug Administration said Tuesday. The FDA has not determined a causal link between the shots and the condition, called Guillain-Barré syndrome, or GBS.
FDA GBS Warning in the Prescribing Info
3 days ago · Abrysvo was initially approved on May 31, 2023, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.
About GSK’s RSV 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.
GSK’s RSV vaccine, Arexvy, accepted under Priority Review in US …
Feb 6, 2024 · GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted under priority review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease.
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...