US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
BioPharma Dive2d
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 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 ...
'Decapitated': More top vaccine regulators out at FDA, threatening new approvals
More top vaccine regulators at the FDA have either left or been forced out, which could hobble the agency's ability to ...
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 ...
Dramatic HHS cuts leave US ‘weaker as a nation,’ says top FDA vaccine official forced out under Kennedy
Sweeping job cuts and reorganizations taking place at the US Department of Health and Human Services under Secretary Robert F ...
FDA Delays Full Approval Decision On Novavax's COVID-19 Vaccine
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.
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 ...