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 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.
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.
BioSpace8h
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.
Vaccine stocks tumble: Moderna, Novavax, Pfizer fall after top FDA official resigns over RFK Jr. anti-vax views
Vaccine stocks are down after the health agency's top immunization official announced the move Monday, citing Secretary ...
US drug regulator delays Novavax COVID vaccine approval
The US drug regulator has missed a deadline for granting full approval to Novavax's COVID-19 vaccine, the company said ...
STAT7h
Pharmalittle: We’re reading about a pharma tariff exception, FDA inspection cutbacks, and more
The Trump administration carved out an exception for pharmaceuticals from the president's new tariff regime, at least for now ...
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 ...