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 ...
US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns
The U.S. Food and Drug Administration has put on hold a trial of Novavax's COVID-influenza and its standalone flu vaccines ...
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 ...
MassDevice5h
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.
FierceBiotech12h
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 ...
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.
BioSpace9h
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 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 ...
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 ...
FDA Puts Clinical Hold On Novavax COVID-19-Influenza Combo Vaccine Candidate; Stock Tumbles
Wednesday said the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its COVID-19-Influenza ...
Novavax's stock tumbles 19% after FDA puts clinical hold on COVID and flu vaccine candidates
Novavax Inc.’s stock tumbled 19% early Wednesday after the company said the Food and Drug Administration has placed a clinical hold on its COVID-19-and-flu combination and stand-alone flu vaccine ...
FDA authorizes 1st over-the-counter combo flu and COVID test outside of emergency use
The FDA has authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use, which delivers ...