Novavax says FDA put hold on combination Covid-flu shot and influenza vaccine; shares plunge
Novavax said the Food and Drug Administration has put a hold on its application for a combination shot targeting Covid and ...
Axios Vitals on MSN13h
FDA halts trial of Novavax COVID-flu combo shot
The Food and Drug Administration halted Novavax's trial of a combination vaccine for COVID and influenza, as well as a ...
US FDA Pauses Novavax's Trial of Combo COVID-Flu Shot on Safety Concerns
(Reuters) - The U.S. Food and Drug Administration has put Novavax's trial of an experimental COVID-flu vaccine combination on ...
Novavax Stock Plunges After FDA Pauses Covid, Flu Vaccine Trials
Novavax shares tumbled after the Food and Drug Administration put a clinical hold on its testing applications for a combined ...
FDA Freezes COVID-Flu Combo Vaccine Trial Over Safety Concern
The U.S. Food and Drug Administration has put a trial of Novavax’s COVID-influenza and its standalone flu vaccines on hold after a participant who took the combination shot reported nerve damage, the ...
FierceBiotech16h
FDA puts Novavax's phase 3 plan for pair of vaccine programs on hold over nerve disease case
Novavax’s plans for growth outside of its COVID program have been thrown into chaos after the FDA put the biooharma's flu ...
MassDevice9h
FDA revokes EUA for Cue Health COVID-19 tests
The FDA today issued a notice classifying the recall of Cue Health COVID-19 tests as Class II and revoking the tests' EUA.
FDA authorizes over-the-counter combined COVID-19 and flu home test
Healgen Scientific's combined COVID-19 and flu test gives people a new way to check what's causing their symptoms, FDA says.
FDA Puts Speed Breaker On Novavax's COVID/Flu Combo Shot Trial On Concerns Related To Damaged Nerves
The clinical hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S. who received the vaccine in January ...
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Novavax Shares Slide as FDA Pauses COVID/Flu Vaccine Candidates
The clinical hold affects Novavax’s COVID-flu combo and standalone flu vaccines, which were on the cusp of Phase III testing.
FDA approves the first at-home test for COVID-19 and the flu, no prescription needed
The Food and Drug Administration has granted authorization of a COVID-19 and flu test that can be used without a prescription ...
Novavax Plunges After FDA Hold on Flu, Covid Vaccine Work
Novavax Inc. shares fell as much as 24% after US regulators placed a hold on the company’s experimental influenza and Covid-19 combination vaccines because a study volunteer developed a serious nerve ...