Novavax Gets FDA Approval To Resume Testing 2 Vaccines

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 clears Novavax to resume trials of Covid-19 and flu combo vaccine
standalone flu vaccine called tNIV. Robert Walker, Novavax’s chief medical officer, said that the FDA “satisfactorily addressed all clinical hold issues.” Walker confirmed that trial activities will resume as soon as possible. Novavax’s upcoming ...
Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
The company said further information supported its contention that the vaccine did not cause ... COVID-19-flu and standalone flu vaccines. The company explained that the U.S. Food and Drug Administration (FDA) removed its clinical hold on the studies ...
FDA lifts clinical hold on Novavax' combo COVID-19 flu jab study
The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates,
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 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 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
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