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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 ...
BioSpace3d
Former FDA Officials Sound Alarm: Visible Changes May Be ‘Tip of the Iceberg’
In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER ...
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 COVID-19 vaccine, a source familiar with the matter told Reuters on Wednesday.
BioSpace16d
FDA Misses Review Deadline for Novavax’s COVID-19 Shot, Days After Marks’ Resignation
The FDA was scheduled to release its decision on Novavax’s updated, protein-based COVID-19 vaccine on April 1, but the agency ...
Fierce Pharma1d
RFK Jr.'s FDA staff cuts claimed key user fee negotiators, threatening renewal talks with pharma: Reuters
As the prospect of sector-specific tariffs under the second Trump administration continues to rattle drugmakers, a more ...
Fierce Pharma1d
Recently departed CBER director warns FDA staff cuts could upend drug review timelines as early as next year: BMO
One of the FDA’s recently departed top officials is weighing in on the wide-ranging staff cuts at the agency and how they ...
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: 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 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 ...
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 ...
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.
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 COVID-19 vaccine, the company told Reuters on Wednesday. The delay comes on ...