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 pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
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.
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.
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