News

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 ...
Novavax shares tumble after U.S. health secretary raises concerns over COVID shot's efficacy
By Kamal Choudhury (Reuters) -Vaccine maker Novavax's shares plunged nearly 20% at market close on Thursday, after Health and ...
CNN on MSN9d
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 ...
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 ...
Anti-vaccine sentiment may derail vaccines already awaiting FDA approval, experts fear
Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...
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 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 ...
Fierce Pharma8d
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 ...
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.
Novavax slides after RFK Jr. casts doubts about COVID vaccine
Shares of Novavax (NVAX) are under pressure on Thursday following Robert F. Kennedy Jr.’s comments on the company’s COVID shot approval delay. The Secretary of Health and Human Services pointed to the ...