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FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License ...
STAT4d
Health secretary RFK Jr. declares certain vaccines have ‘never worked,’ flummoxing scientists
Beyond the pending Novavax approval, the FDA must in the coming weeks advise Covid vaccine manufacturers on how to update their shots for the 2025-2026 respiratory season. The agency is also ...
Novavax: Regulatory Uncertainty Creates Risk And Opportunity For Beaten-Down Vaccine Developer
Novavax shifts to a partnership-focused strategy with a $500M Sanofi deal. Despite regulatory and competitive risks. See why ...
Fierce Pharma10d
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 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 ...
Ex-FDA Official Is Worried About the FDA’s New “Anti-Vaccine Tone”
Dr. Peter Marks, an ex-FDA vaccine official, is warning of a fundamental change at the agency—where vaccine skepticism now ...
Novavax says ‘no official response’ from FDA on BLA status for COVID shot
In an emailed statement to The Fly, Novavax (NVAX) said, “As we have previously stated, we believe that our Biologics License Application for ...
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 ...
Novavax’s Covid vaccine delayed in FDA review
Novavax started the week hoping the FDA would issue a full approval of its Covid vaccine. But the decision never came.
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 ...
Novavax shares tumble after U.S. health secretary raises concerns over COVID shot's efficacy
Vaccine maker Novavax's shares plunged nearly 20% at market close on Thursday, after Health and Human Services Secretary ...
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 ...