News

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.
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 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 ...
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 ...
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 ...
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” ...
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 ...
CNN13d
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The terms need to be negotiated before Novavax’s vaccine could be granted full approval, the source said, declining to be named because they weren’t authorized to speak on behalf of the FDA.
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 ...