News

Updated Covid vaccines for the fall may be in jeopardy under Kennedy's new rules
If the FDA deems Pfizer’s and Moderna’s updated vaccines “new” products, it’s extremely unlikely the doses would be ready for ...
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 ...
FDA chief 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 ...
Fierce Pharma9h
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 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 ...
STAT3d
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 ...
BioSpace10d
Makary Discusses Expedited Rare Disease Approvals Pathway, ‘Public Distrust’ in New Interview
In an interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary introduced a new mechanism-driven ...
FDA commissioner: No major reorganization, just smart reforms
Dr. Marty Makary had just finished his last surgery at Johns Hopkins when he stepped into one of the most powerful roles in ...
FDA commissioner says pulling COVID vaccine for children will be ‘welcomed’
Speaking at Semafor's World Economy Summit, Marty Makary diverged from Robert F. Kennedy Jr.’s stance on vaccine ...
Seasonal COVID shots may no longer be possible under Trump admin
Under President Trump, the Food and Drug Administration may no longer approve seasonal COVID-19 vaccines updated for the ...
BioSpace2d
FDA Alumni, Experts Call on Makary To Stand Up Against Agency’s Politicization
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions ...
Novavax Stock Is Up Again. There Are Still Big Questions About the Fate of Its Covid Shot.
Novavax said Monday morning that the Food and Drug Administration was asking the company to run a new trial of its Covid-19 ...