FDA, Novavax and COVID-19

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 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 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.
Novavax sees weak Covid vaccine sales, convinced Sanofi can do better
Novavax has made a smaller splash in the U.S. Covid-19 vaccine market than it had hoped. But it's betting on licensing deals and a pipeline of new vaccines it's now evaluating for R&D.
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,
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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Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
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Novavax Gains Competitive Edge with FDA Clearance and Strategic Collaborations, Earning Buy Rating
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Novavax cuts 2024 revenue forecast again on lower COVID vaccine sales
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