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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 ...
'Show me the data': FDA commissioner reacts to question about Covid vaccine for young Americans
Vaccine maker Novavax is seeking to convert the 2022 emergency authorization of its Covid-19 vaccine into full approval. Yet ...
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 ...
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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 ...
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 chief says they're looking at whether to approve COVID shots for next winter
The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...
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 ...
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 ...
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FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
The FDA was on track to grant Novavax full approval by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss ...
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FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
"We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency," Novavax said in a statement Friday. "PMCs are not unusual with ...