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Novavax says talks with FDA on COVID vaccine approval ongoing calming investor fears
Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...
Novavax swings to profit, says talks with FDA on COVID vaccine approval ongoing
Novavax said on Thursday discussions with the U.S. health regulator on its COVID-19 shot are ongoing and a pathway to ...
COVID Vaccine Maker Novavax Stock Soars 16% - Here's Why
Novavax posts $667 million in Q1 2025 revenue and $2.93 EPS, boosted by Sanofi payments and APA terminations; full-year ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
BioSpace1d
Novavax Sales Jump 600% YoY as COVID-19 Vaccine Still in Limbo at FDA
After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its ...
BioPharma Dive11d
Novavax says vaccine application still ‘approvable,’ despite FDA delay
Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...
COVID vaccine boosters called into question by FDA chief: ‘Void of data’
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
US FDA advisers to discuss COVID-19 vaccine recommendations on May 22
The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...
Novavax rises after massive Q1 beat, guidance raise
Novavax (NVAX) stock jumps 35% as the company raises its 2025 revenue outlook and its Q1 2025 financials surpasses forecasts ...
Chicago Tribune11d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
WASHINGTON — The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional protein-based option for the coronavirus — is ...