FDA, Novavax and influenza vaccine
Novavax says FDA put hold on combination Covid-flu shot and influenza vaccine; shares plunge
The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial.
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 programs on hold in response to a case of nerve disease from a former parti | The phase 2 trial wrapped up in July 2023,
FDA places hold on Novavax’s COVID-influenza combo vaccine
A report of a case of motor neuropathy in a patient who received the vaccine last year has led the FDA to halt its development while more information is gathered.
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 2023. Motor neuropathy is a condition that occurs when the nerves that control movement are damaged.
Novavax reports FDA placed clinical hold on IND for COVID-flu combo vaccine
Novavax announced that the U.S. Food and Drug Administration has placed a clinical hold on Novavax’s Investigational New Drug, or IND, application for its COVID-19-Influenza Combination, or CIC, and stand-alone influenza vaccine candidates.
Novavax’s stock slides 16% after FDA puts clinical hold on COVID and flu vaccine candidates
Novavax Inc.’s stock tumbled 16% early Wednesday after the company said the FDA has placed a clinical hold on its COVID-19-and-flu combination and stand-alone flu vaccine candidates, following a case of motor neuropathy in a participant in a mid-stage trial.
Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines
The vaccine maker said the regulator placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant outside the U.S.
The right time is now to get your flu vaccine, says the FDA
Folks who want solid protection during the cold and flu season should get the influenza vaccine now, the U.S. Food and Drug ...
This Is The Right Time To Get Your Flu Medicine, Says US FDA; Here's Why
If you want protection from the cold and flu, get your influenza vaccine now, the US Food and Drug Administration has ...
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FDA approves first flu vaccine that can be self-administered at home
Friday’s approval from the FDA adds a second option for those eligible to receive ... “Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option ...
FDA Updates Sanofi's FLUBLOK Vaccine Label With New Safety Data For Pregnant Individuals
Sanofi (SNYNF, SNY) said that the U.S. Food and Drug Administration has updated the label for FLUBLOK (Influenza Vaccine) to include ...