News

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 ...
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 ...
The Associated Press on MSN13d
Novavax says its COVID-19 shot is on track for full FDA approval after delay
Copyright 2025 The Associated Press. All Rights Reserved. Copyright 2025 The Associated Press. All Rights Reserved. A vial of ...
As FDA delays Novavax' COVID vaccine approval, patients fight back
By Julie Steenhuysen CHICAGO (Reuters) -Thousands of Americans campaigning for the Novavax COVID-19 booster got some good ...
BioPharma Dive8d
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 ...
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 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 ...
Novavax's COVID-19 Vaccine Nears FDA Full Approval, Stock Jumps
Novavax's COVID-19 vaccine showed fewer side effects than Pfizer's in a Utah study as FDA seeks more data before full ...
The Daily Record (Maryland)6d
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
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 sowing ...