News

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 ...
Fierce Pharma2h
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
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
What's holding up new COVID booster guidance from the FDA
The Food and Drug Administration was set to release new guidance on COVID booster shots ahead of the fall season, but that's ...
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 ...
HHS to require placebo testing of ‘all new vaccines,’ raising questions about approval of updated Covid-19 shots
The US Department of Health and Human Services said it will require that all new vaccines be tested in placebo-controlled ...
FDA Commissioner: No Major Reorganization, Just Smart Reforms
In an exclusive interview with physician and writer Dr. Jeremy Faust on Substack, Makary opened up about his first weeks on ...
Fierce Biotech4h
Moderna's flu/COVID combination vaccine hit by deprioritization, FDA delay
Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut about $1.5 billion from its ...
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 ...
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 ...
Claims That the FDA Has Approved Ivermectin to Treat COVID-19 Are False
At the peak of the COVID-19 pandemic, many vaccine skeptics turned to ivermectin, a medication proven to fight off parasitic ...
FDA appears to be slow-walking vaccine approvals
Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...