A company that makes one of the three COVID-19 vaccines available in the United States said on April 23 that its shot is on track for regulatory approval, after regulators declined to grant approval before a deadline.
“We believe that our Biologics License Application (BLA) is approvable based on conversations with the U.S. Food and Drug Administration (FDA),” Novavax said in a statement.
“We have recently received formal communication from the FDA in the form of an information request for a postmarketing commitment (PMC) to generate additional clinical data. We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible.”…