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Novavax, FDA and Covid-19
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.
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.
FDA removes clinical hold on Novavax’s COVID-19-influenza combo vaccine
The FDA had put a clinical hold on Novavax’s COVID-19-influenza combo vaccine after an adverse event in a patient.
FDA lifts clinical hold on combined COVID-19-influenza vaccine trials
Novavax received clearance from the
FDA
to move forward with phase 3 clinical trials for its COVID-19-
influenza
combination (CIC ... confirming that the event was not related to the investigational
vaccine
. With the clinical hold now lifted, Novavax ...
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: 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
USFDA removes clinical hold on Novavax COVID Influenza combination, stand alone Influenza Phase 3 trial
Gaithersburg: Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, has announced that the U.S. Food and Drug Administration (USFDA) has removed the
Yahoo Finance
4d
U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial
today announced that the U.S. Food and Drug Administration (
FDA
) has removed the clinical hold on Novavax's Investigational ...
STAT
11d
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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