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FDA

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’s principal deputy commissioner intervened.

April 3, 2025

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2 min read

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Tristan Manalac

Pictured: Novavax/Getty Images, STR/NurPhoto

Vaccines

After Missed Decision Deadline, Novavax Says COVID-19 Shot ‘Approvable’

The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.

April 24, 2025

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2 min read

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Tristan Manalac

COVID-19

Novavax Applies Lessons Learned From Turbulent COVID-19 Experience

As sales of its COVID vaccine plummet, Novavax is looking ahead toward other novel vaccines, brought to market with the help of the company’s pharma partners—something it opted not to do as the pandemic swept the globe in 2020.

March 10, 2025

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6 min read

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Heather McKenzie

Balloons in the cloudy sky paper cutting art Sky background clouds, scene 3D illustration

Vaccines

Two Years Into Novavax Reset, CEO Jacobs Hunts for Silver Linings

After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.

January 28, 2025

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6 min read

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Annalee Armstrong

FDA

UPDATE: FDA Lifts Clinical Hold on Novavax’s COVID/Flu Vaccine Candidates, Clears Phase III Trial

Novavax’s shared jumped 12% in pre-market trading on the news.

November 11, 2024

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2 min read

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Annalee Armstrong

Press Releases

SHIELD-Utah Study Shows Novavax’s COVID-19 Vaccine Induces Lower Reactogenicity Symptoms Compared to mRNA

April 16, 2025

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7 min read

Press Releases

Novavax to Participate in Upcoming March 2025 Investor Conferences

February 28, 2025

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1 min read

Healthcare worker administers a vaccine to a patient

COVID-19

Novavax Catches Up to Competitors With FDA Approval for Updated COVID-19 Boosters

Unlike Pfizer/BioNTech and Moderna, Novavax does not use mRNA technology for its COVID-19 vaccine, instead opting for a recombinant version of the virus’ spike protein to elicit protection.

September 3, 2024

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2 min read

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Tristan Manalac

Press Releases

Novavax Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights

February 27, 2025

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17 min read

BioCapital

Novavax to Participate in 2024 Jefferies Global Healthcare Conference

Novavax, Inc. today announced it will participate in the 2024 Jefferies Global Healthcare Conference.

May 30, 2024

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1 min read