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FDA removes clinical hold on Covid-19/flu combo trial
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 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 standalone flu vaccines after identifying a safety concern.
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 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 Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.
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).
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
BioPharma Dive
2d
FDA lifts pause on Novavax flu vaccine trials
The
Food
and Drug
Administration
has cleared Novavax to move forward with testing of a combination
vaccine
for ...
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 ...
STAT
5d
What Trump and Robert F. Kennedy Jr. might do to undermine vaccines — and what they likely can’t
RFK Jr. may push the FDA to gather more data, and could try to fill the CDC's Advisory Committee on Immunization Practices ...
6d
RFK Jr. Says 'I've Never Been Anti-Vaccine'—Here Are the Facts
Robert F. Kennedy Jr. may have a significant influence on public health matters following Donald Trump's presidential victory ...
WBUR
12d
Nasal spray vaccines may be coming, and could be better than shot
Vaccines delivered through a spray into the nose could offer better protection and fewer side effects than traditional vaccine shots in the arm.
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