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 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 ...
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.
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 ...
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.
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 set to snap six days of losses as shares trade in green
Novavax (NVAX) stock rebounds 2.5% after six days of losses amid FDA approval delays for its COVID-19 vaccine.
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 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.
Novavax (NasdaqGS:NVAX) Sees 21% Weekly Drop As Leadership Changes Shake Market
Novavax (NasdaqGS:NVAX) recently experienced a significant decline of 21% over the past week, coinciding with leadership changes, including the retirement of longtime Chairman James Young and 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 ...