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 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 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 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 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 ...
Novavax Covid vaccine unlikely to be approved soon, WSJ says
The Food and Drug Administration missed the deadline for making a decision regarding a Covid-19 vaccine from Novavax (NVAX), Liz Essley Whyte ...
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.
Dispute Over Covid Vaccines Casts Doubt On Clover Bio Recovery
It reported revenues of 38.41 million yuan in the first half of 2024 and a net loss of 903 million yuan, hit by falling ...
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 ...
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 ...