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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 ...
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 ...
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 ...
Dermatology Advisor14h
Novavax COVID Vaccine Moves Closer to Full FDA Approval
The FDA is expected to unpause the only protein-based COVID-19 vaccine's transition from emergency approval to full approval.
Fierce Pharma1d
FDA puts up placebo testing requirement for new vaccines, potentially hitting COVID shot makers the hardest: reports
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...
STAT4d
U.S. health officials inject new uncertainty into approval process for Covid boosters
Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible ...
CIDRAP4d
More FDA uncertainty roils full approval for Novavax COVID vaccine
Novavax's COVID vaccine was approved under an emergency use authorization in August 2022, and the company has pursued 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 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 ...
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 ...
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” ...
ABC News5d
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 ...