News

Novavax: Grandiose Ambitions, Smart Strategy, But FDA Decision Adds To Challenges
Novavax shows financial improvement but faces vaccine challenges. Read why I rated NVAX stock as 'Hold' and what risks and ...
BioPharma Dive12m
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 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 ...
MPR4h
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the FDA means a product can stay on the market even after a health emergency ...
FDA still negotiating whether to grant full approval to Novavax COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) is still negotiating whether to grant full approval to Novavax's COVID-19 vaccine ...
US FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports
Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously ...
Novavax Falls on Report That FDA Wants New Covid Vaccine Trial
Novavax Inc. shares fell after the Wall Street Journal reported that US regulators asked the company to conduct another ...
FDA’s job cuts paint mixed picture for drugmaker’s R&D plans
After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.
Novavax shares soar after FDA request raises hope for COVID vaccine approval
Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...
FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports
(Reuters) -Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after ...
WMUR1d
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 ...
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 ...