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 ...
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, according to KFF Health News, are also pressing regulators to revoke federal ...
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 ...
Fierce Pharma1d
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 ...
FDA Punts on Major Covid-19 Vaccine Decision After Ouster of Top Official
The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.
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 ...
FDA Delays Full Approval Decision On Novavax's COVID-19 Vaccine (UPDATED)
Novavax's COVID-19 vaccine received FDA Emergency Use Authorization, but full approval faces delays as regulators request more data beyond the April 1 deadline.
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.
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 ...
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 ...
CNN2d
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 ...