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 Covid-19 Vaccine Decision
The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.
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 ...
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 ...
'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 ...
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 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 ...
Ousted vaccine official says Kennedy sought data to justify anti-science stance, WSJ reports
Peter Marks, the FDA's top vaccine official ousted by Robert F. Kennedy Jr. said the U.S. health secretary's team sought ...
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.
Clinical Advisor1d
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.
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 ...
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, ...