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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.
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 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 ...
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 ...
BioPharma Dive10d
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” ...
FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot
A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say ...
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 ...
pharmaphorum10d
Does the Novavax delay augur a COVID vaccine policy change?
In addition, HHS Secretary Robert F. Kennedy Jr addressed the delay in Novavax's approval in a CBS interview earlier this ...
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 ...
Chicago Tribune10d
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 ...