US FDA lifts clinical hold on Novavax's combo COVID-flu shot
The U.S. 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 a safety concern was found to be unrelated to the combination shot,
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.
Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.
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
FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine
The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.
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) and standalone influenza vaccines. The FDA lifted a clinical hold that had been placed on Novavax's investigational new drug application after the company addressed concerns related to a serious adverse event reported in a phase 2 trial,
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