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 ...
Moderna Shares Fall on Vaccine Sales Miss, Delay in FDA Review
Moderna Inc. shares declined after the company’s first-quarter vaccine sales missed estimates and it disclosed a delay in the ...
Kennedy Issues Demands for Vaccine Approvals that Could Affect Fall Covid Boosters
The agency suggested that clinical trials in humans may be required for updated Covid shots, raising questions about whether ...
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 ...
Fierce Pharma7h
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 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.
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 ...
WUFT30m
RFK Jr. to require placebo-controlled studies for new vaccines
The Department of Health and Human Services says it will require new vaccines to be tested against a placebo, which could ...
Why is there pushback to RFK Jr.‘s plan to test new vaccines vs. placebos?
Per the Post, which first reported the story, “‘All new vaccines will undergo safety testing in placebo-controlled trials ...
Fierce Pharma5h
Moderna targets more cost cuts amid broader vaccine market uncertainty under HHS secretary RFK Jr.
On a Thursday conference call with investors, Moderna CFO Jamey Mock outlined a roadmap for the mRNA specialist to lower its ...
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 appears to be slow-walking vaccine approvals
Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...