News

FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.
Fierce Pharma19h
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 ...
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 ...
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 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 ...
STAT5d
U.S. health officials inject new uncertainty into approval process for Covid boosters
Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid-19 vaccine ... took to social media to defend the FDA’s controversial handling of the ...
Pulmonology Advisor1d
Novavax COVID Vaccine Moves Closer to Full FDA Approval
Novavax's protein-only vaccine is once again expected to move from emergency approval to full approval status following a pause.
Medpage Today on MSN20hOpinion
Inside the FDA: Low Morale and Uncertainty Plague Staff
Several current and former FDA employees who spoke to Inside Medicine on the condition of anonymity have come to see the ...
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 COVID-19 vaccines for next winter, citing a lack of data on booster shots.
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 ...