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GSK, Pfizer and RSV
GSK, Pfizer RSV shots must warn about rare paralysis risk
Barré for every million doses given.
GSK and Pfizer's RSV vaccines to carry warnings of neurological disorder risk
GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing a rare neurological disorder, the U.S. Food Drug Administration said on Tuesday.
RSV vaccines from Pfizer, GSK take another hit with new FDA warning mandate
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 neurological condition that can cause paralysis.
FDA adds warning to RSV shots from GSK, Pfizer
Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.
Guillain-Barre Syndrome explained as 2 RSV vaccines flag neurological 'risk'
As for GBS itself, this neurological ailment can be severe, attacking nerves and warranting hospitalisation for weeks or months. It can influence a variety of nerves from senses to movement, and even heart rhythm, with initial symptoms manifesting typically in the limbs.
GSK, Pfizer RSV Shots Required to Carry Guillain-Barré Syndrome Warnings
A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s Arexvy and Pfizer’s Abrysvo, prompting the regulator to require adjustments to the vaccines’ labels.
Pharmalittle: We’re reading about FDA commish’s parting thoughts, a warning on RSV shots, and more
He also articulated a very specific doctrine about the role of an FDA commissioner, one that is limited in its power and leaves many controversial decisions to career government officials. Califf said he would not directly comment on any individual,
Pfizer And GSK's RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder
FDA updates safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines, citing increased Guillain-Barré syndrome risk. Study estimates 7-9 excess GBS cases per million doses.
RSV vaccines to carry neurological disorder risk warning after new research
On Tuesday, January 7, the FDA announced it would now be requiring GSK and Pfizer’s RSV vaccines to hold warnings of a risk of Guillain-Barré syndrome (GBS). This is after post market analysis by the American regulator.
GSK, Pfizer RSV vaccines to carry warnings of GBS, Reuters reports
GSK (GSK) and Pfizer (PFE) vaccines for respiratory syncytial virus, or RSV, will carry warnings that they can increase the risk of developing
48m
on MSN
'Quad-demic' overwhelms US hospitals as flu, Covid, RSV, and norovirus surge: Tips to stay safe
Hospitals in the USA are overwhelmed with a surge in patients due to a 'quad-demic' of flu, Covid-19, RSV, and norovirus.
Zacks.com on MSN
3h
Pharma Stock Roundup: FDA Updates for JNJ, GSK, PFE, NVO's Expanded Deal
This week, the FDA granted priority review status to J&J’s JNJ application seeking approval of key pipeline candidate ...
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