FDA, COVID and Novavax

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 after a safety concern was found to be unrelated to the combination shot,
FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine
Novavax has received the green light from the US Food and Drug Administration (FDA) to resume clinical trials for its Covid-19 and influenza combination vaccine (CIC) and standalone influenza vaccines after a month-long clinical hold.
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.
Novavax: FDA removes clinical hold on Covid-19/flu combo trial
Novavax (NVAX) announced that the U.S. FDA has removed the clinical hold on Novavax’s Investigational New Drug application for its
Novavax to Move Forward With Covid-19-Flu Vaccine After FDA Lifts Clinical Hold -- Update
Novavax is already poised to benefit from a separate combined Covid-flu vaccine via a deal with Sanofi announed earlier this year. Under the $1.4 billion co-licensing agreement, announced in May, Sanofi will have the sole right to use Novavax's existing Covid-19 vaccine in combination with its own flu vaccine.
Novavax stock soars as FDA removes clinical hold on its COVID and influenza shot
The U.S. Food and Drug Administration (FDA) has lifted its hold on a late-stage trial for Novavax’s COVID-influenza combination and standalone flu vaccines, the company reported on Monday (NASDAQ:MNDY).
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Facing a dialogue with RFK Jr., a top FDA official mounts a public defense of vaccines
Facing with a dialogue with RFK Jr., a top FDA official mounts a public defense of vaccines — and pleads for open minds.
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Still Need a Flu Vaccine? Now May Be a Good Time to Get One
Protection from shots like the flu vaccine typically takes a couple of weeks to kick in, so getting one now may offer ...
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Patients could get at-home flu vaccine as early as next year
But next year, you could get vaccinated for the flu at home. Just last month, the FDA approved FluMist, a nasal-spray ...
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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 ...
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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 ...
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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, ...
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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 ...