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Novavax to Move Forward With Covid-19-Flu Vaccine
FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine
standalone
flu
vaccine
called tNIV. Robert Walker, Novavax’s chief medical officer, said that the
FDA
“satisfactorily addressed all clinical hold issues.” Walker confirmed that trial activities will resume as soon as possible. Novavax’s upcoming ...
US FDA lifts clinical hold on Novavax's combo COVID-flu shot
The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines, the company said on Monday. Shares of the company rose about 9% in premarket trading.
FDA Lifts Hold on COVID-Flu Combo Vaccine Trial
The FDA has lifted its clinical hold on Novavax's combined COVID-19 and influenza vaccine trial, finding no link between the vaccine and a reported adverse neurological event. This decision enables Novavax to resume late-stage testing.
The Pharma Letter
13h
FDA lifts clinical hold on Novavax' combo COVID-19 flu jab study
The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug (IND) application for ...
BioPharma Dive
1d
FDA lifts pause on Novavax flu vaccine trials
A trial participant who’d received the shot in Jan. 2023 later developed motor neuropathy, or muscle weakness, leading the ...
STAT
8d
A Q&A with the FDA’s top vaccine regulator amid a fresh wave of disinformation
A fresh wave of disinformation about vaccines is flaring amid the 2024 campaign. The FDA's top vaccine official believes ...
16h
on MSN
Novavax Stock is Slipping After the Vaccine Maker Cut its Outlook Again
Novavax shares dropped Tuesday morning after the company slashed its full-year outlook when it announced its third-quarter ...
JD Supra
4d
FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside of Traditional Health Care Settings
On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, ...
Business Wire
1d
Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial
today announced that the U.S. Food and Drug Administration (
FDA
) has issued a “Study Can Proceed” notification for the Company’s Investigational New Drug (IND) application, ARCT-2304, a ...
KSL
1d
FDA lifts clinical hold on Novavax's combo COVID-flu shot
The Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its ...
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