'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 ...
BioPharma Dive1d
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 ...
Ousted Vaccine Official Says Kennedy Sought Data to Justify Anti-Science Stance, WSJ Reports
(Reuters) -Peter Marks, the FDA's top vaccine official ousted by Robert F. Kennedy Jr. said the U.S. health secretary's team ...
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 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 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 ...
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 ...
MPR1d
FDA Approves Freeze-Dried Formulation of Mpox, Smallpox Vaccine
The live vaccine is produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus.
CIDRAP3d
FDA approves freeze-dried version of Jynneos mpox vaccine
Yesterday the US Food and Drug Administration (FDA) approved a freeze-dried formulation of Bavarian Nordic's mpox vaccine, ...