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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 ...
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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 Punts on Major Covid-19 Vaccine Decision After Ouster of Top Official
The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.
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.
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 ...
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FDA delay on Novavax vaccine approval could be bellwether for vaccine sector: BofAS
Kennedy Jr., and that the deputy commissioner at the FDA intervened in the Novavax decision, are fueling concerns about the anti-vaccine beliefs of RFK Jr. and the potential impact to the industry.
Fierce Pharma2d
Former 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 ...
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 ...
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 ...
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 ...
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 ...
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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 ...