FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
US FDA misses deadline for decision on Novavax's COVID-19 vaccine
The U.S. Food and Drug Administration has missed its deadline for making a decision on traditional approval for Novavax's ...
FDA misses approval deadline for Novavax’s COVID-19 vaccine
The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...
FDA misses deadline for decision on Novavax's COVID-19 vaccine, source says
The U.S. Food and Drug Administration has missed its deadline for making a decision on traditional approval for Novavax's ...
FDA delay on Novavax vaccine approval could be bellwether for vaccine sector: BofAS
The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...
Fierce Pharma2d
Amid FDA tumult, agency misses decision deadline on Novavax's COVID shot
Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...
BioSpace2d
FDA Misses Review Deadline for Novavax’s COVID-19 Shot, Days After Marks’ Resignation
The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1.
Novavax bid for full approval of COVID vaccine stymied by FDA - report
The FDA delays full approval for Novavax's COVID-19 vaccine, citing the need for additional data. Read more here.
InsideNoVa1d
FDA Delays Final Approval of Novavax COVID Vaccine
The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, ...
Top Trump FDA official Brenner hits pause on Novavax Covid-19 vaccine decision
The move comes amid HHS Secretary Robert F. Kennedy Jr.’s decision to force out the top official responsible for reviewing such vaccines, Dr. Peter Marks, and put his deputy Julie Tierney on ...
Novavax believes BLA ‘ready for approval,’ waiting on action from FDA
Novavax (NVAX) issued the following update on the FDA BLA for the company’s COVID-19 vaccine: “Novavax can confirm that April 1, 2025, was the ...
CNN3d
FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the ...