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 ...
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 ...
Fierce Pharma2d
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 ...
Kennedy Issues Demands for Vaccine Approvals That Could Affect Fall Covid Boosters
The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...
STAT3d
How Marty Makary’s FDA is embracing a more skeptical view of vaccines
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
Truthout1h
FDA Reverses Course, Rehires Staff Handling Public Records After Mass Layoffs
The layoffs had decimated the workforce that processes Freedom of Information Act requests across FDA centers.
In reversal, FDA rehires staff tasked with releasing public records
The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...
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 ...
BioPharma Dive5d
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” ...
HHS touts universal flu, coronavirus vaccine initiative while casting doubt on future of seasonal Covid-19 shots
The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat ...